company directory
Contract Research Organizations
Find your German partner
1 Summary
In their constant strive for innovation, outsourcing has become essential for biopharmaceutical companies. Contract research organizations (CROs) are independent service providers that help biopharmaceutical companies manage their drug development process. With their expertise in preclinical and clinical R&D, CROs have become key enablers and strategic partners for the biopharmaceutical industry.
Germany provides access to a vibrant and highly diversified contract research landscape. CROs deliver high-quality services along the drug development pathway and meet the exacting demands of drug developers – from end-to-end development to tailored contract research activities.
HEALTH MADE IN GERMANY has compiled this directory to give you an overview of companies active in Germany’s CRO sector. The purpose of this directory is twofold: First, to provide an introduction to the country’s contract research landscape. And secondly, to help you to quickly find services of interest to your business. As such, the directory is an invaluable resource that also provides the tools necessary for you to take the next step – establishing contact with the appropriate partners in your area of activity. Content
INTRODUCTION 5 Managing the drug development process 5 CROs as key players in pharma innovation 6 Growing and maturing CRO landscape 7 Different models of cooperation 7 Spectrum of services offered by CROs 7 Strengths of CROs in Germany 8 Drug discovery and preclinical studies 9 Clinical CRO landscape
10 COMPANY PROFILES 11 Company and technology overview 16 Company profiles
72 OUR PARTNERS Industry Associations
74 OUR SERVICES
75 CONTACT
75 IMPRINT
3 INTRODUCTION Contract research in Germany Outsourcing research has become essential for biopharmaceutical companies in their hunt for innovation. Contract research organizations (CROs) help them to manage their drug development process. With their expertise in preclinical and clinical R&D, CROs in Germany are key enablers and strategic partners in the complete drug development pathway.
Contract research organizations (CROs) are laboratory services, other functions associated independent service providers in the drug with getting new drugs or devices to market. development process. They provide a range of services to pharmaceutical, biotechnol- There are more than a dozen global full-service ogy, and medical device companies as well CROs that offer the complete spectrum of serv- as governments, academic institutions, and ices needed for drug development. These larger other research entities. These services can CROs generally provide services to large pharma encompass all phases of the drug develop- companies. A growing number of smaller speci- ment life cycle – from compound selection, ality CROs provide tailored services that focus discovery, pre-clinical and clinical research on a particular stage of clinical development or to post-approval services including commer- offer defined services within a specific thera- Outsourcing cialization, safety assessment, monitoring, peutic niche – largely addressing smaller and has become and consulting. mid-sized pharma clients. This flexibility and a standard know-how is also becoming increasingly attrac- procedure in the Managing the drug development process tive for Big Pharma clients. Germany provides age of agile and Contract research organizations help biophar- access to a broad range of CROs in a vibrant and flexible pharma maceutical companies manage the drug devel- highly diversified contract research landscape development. opment process. Thanks to their expertise, they that covers all stages in drug development and are often able to do so more cost effectively value creation. and with a shorter time-to-market than in- house R&D departments. CROs fall into several CROs as key players in pharma innovation categories. Preclinical CROs test drug or device The innovation landscape of the global pharma candidates for client businesses before the com- industry has changed dramatically over the past pounds or devices undergo clinical or human decade. The whole industry – and Big Pharma in testing. This might include helping a client to particular – has experienced stricter regulatory synthesize compounds, run biochemical assays requirements, escalating commercialization costs or conduct animal studies. Clinical CROs focus and patent expirations on key blockbuster drugs. on clinical trial services such as medical writing, In order to increase drug-discovery program regulatory submissions, project management, success rates and reduce R&D costs, pharmaceu- monitoring, data management and analysis, tical companies seek to improve and accelerate
The industry’s pipeline includes a diverse mix of new technologies
Conventional therapies Other biologics Proteins and peptides Antibodies Cell and gene therapies
Interventional phase 1–3 projects in thousands Compound annual growth rate 2015–2017 in percent
5 11
10
4 2 15
9 3
2 Share 2017 pipeline in percent
1
0 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 60 5 10 13 12
Original from McKinsey&Company (Source: PharmaProjects, 2017)
5 introduction
for the biopharmaceutical industry. The current situation has evolved against the backdrop of an innovation landscape driven by exponen- tially growing biomedical information, powerful emerging technologies, and the increasing im- portance of interdisciplinary collaboration. These developments allow drug makers to cover a broader range of medical needs than in the past. The pharma pipeline has also diversified and is moving from one dominated by small molecules and monoclonal antibodies to a wide spectrum of new technologies and modalities. Examples of this include immuno-oncology moving from a niche interest to the mainstream, the dawn of cellular therapies, and the resurgence of gene therapies. Enhanced drug complexity brings with it an even higher complexity of associated clini- cal trials, requiring special planning, conducting and analyzing expertise.
Growing and maturing CRO landscape every stage of the drug development process. The CRO industry has been growing steadily. It Pharmaceutical companies are increasingly turn- has benefited from recent downsizing trends in ing to agility and flexibility concepts in order to combination with growing R&D pipelines in Big reduce costs and speed up time-to-market for Pharma, as well as from a proliferation of small- novel therapeutic and diagnostic products. They er drug makers (Tufts CSDD 2019). Outsourcing are downsizing their in-house capacities and their R&D to CROs allows smaller or sometimes increasingly outsourcing their research activi- fully virtualized companies to manage drug ties to independent service providers. With the development programs with minimal infrastruc- advent of a maturing CRO industry, outsourcing ture. CRO market forecasts vary among differ- has become a standard procedure in pharma ent analysts. In 2018, the global CRO services R&D. As a result, CROs have become key players market was estimated to be worth USD 37
Global CRO market and penetration rates (In-house vs. Outsourced) in percent
In-house (LHS) Outsourced (LHS) Global CRO development spending (RHS)
100% 45 Global CRO market in bn USD 40 75%
35
50%
30
25% 25
0% 20 2013 2014 2015 2016 2017 2018 2019 2020
Original: resultshealthcare.com (Source: Baird, 2015; CRO Industry Primer, Credit Suisse, 2016; 2017 CRO Market Size Projections 2016–2021, ISR Reports, 2017)
6 Contract Research Organizations | health-made-in-germany.com billion (Results Healthcare “CRO sector” 2019). CRO market size by activity The outsourcing penetration level is expected to in billion USD increase to 60 percent in 2020. Market research- ers predict that more than one third of all global Central Lab 2.0 (4%) Post-Approval 23.2 (45%) drug-discovery research will be outsourced to CROs by 2021 (Kalorama Information “Outsourc- Prelinical 4.8 (9%) ing in Drug Discovery” report 2018).
Different models of cooperation The way biopharma companies work with CROs Clinical 22.0 (42%) has changed tremendously. Once driven by “tac- tical” or “functional outsourcing” considerations, the CRO industry now takes on a much larger and more complex role in pharma R&D. For the pharma client, CROs have become strategic de- Source: Credit Suisse (Company data, EvaluatePharma, Credit Suisse estimates) velopment and cooperation partners that base their business model on enabling technologies that guarantee higher quality and more efficient home to a strong network of specialized CROs R&D process execution. Nowadays, there are covering a broad range of services support- various models of collaboration between spon- ing drug developers to remain innovative and sors and CROs. These include the outsourcing of competitive, flexible and agile. The versatility functional teams (“resourcing”), asset transfer, and strength of the German CRO landscape is and risk sharing. It is clear that not only the a solid reference point for collaboration at the number of CROs has increased, but that they international level. have grown by accumulating knowledge and expertise beneficial to their clients. The majority of the 112 German contract research providers presented in this guide fall Spectrum of services offered by CROs into the category of small and medium-sized R&D tasks that biopharma companies choose to enterprises (SMEs). This directory of companies outsource include a wide spectrum of activities mirrors the multifaceted nature of the research from basic research to late-stage development. services offered by CROs in Germany along the The clinical and post-approval stages are the value chain. Not all companies exclusively offer most complex and regulatory intense stages of research services − many carry out their own development. Therefore these are the stages drug research and development but also offer where clients require the most input from contract research services as a side activity. specialist outsourced providers. This is reflected by the size of the respective market (see figure CRO market size by activity).
Strengths of CROs in Germany As part of this dynamic global landscape, there are several hundred preclinical and clinical CROs based in Germany that can deliver high-quality services along the drug development pathway – from end-to-end development to tailored contract research activities. Germany is the top pharma market in Europe and number four worldwide. It is also a heavyweight in medi- cal biotechnology. The range of advanced high technologies on offer, an excellent biomedical research and clinical infrastructure makes the German market truly unique. Germany offers a vital and highly diversified contract research landscape, with CROs covering all stages of drug development and value creation. The county is
7 Drug discovery and preclinical studies molecules is another priority area for contract Some companies focus on the synthesis of research service providers. Drug target discovery biomolecules such as DNA, RNA and peptides and molecular modelling of substances require or the synthesis of small chemical molecules – the use of powerful bioinformatic and chem- all vital stages in pharmaceutical development. informatic tools by necessity. Other companies Others specialize in the analysis of those are occupied with determining the pharma- molecules that involve the characterization of cologic characteristics of active substances structure, function, and expression. A number towards an improved understanding of the effi- of high-profile laboratories in Germany apply cacy and toxicology of drug candidates. Another bioanalytical techniques. This requires high-tech extremely important area is preclinical studies: instrumental set-up and experienced know-how highly specialized cell culture and animal models for data analysis – a field that Big Pharma is are being deployed to elucidate new drug can- increasingly outsourcing to external special- didate uptake, metabolization, excretion, and ists. Screening for potential drug candidate toxicity. A major innovation in the drug discov-
From discovery to the market CRO services along the value chain
Drug discovery Preclinical studies Clinical trials: Post-approval phase I–III
CRO services Target identification Pharmacokinetics & Planning, Post-approval studies offered & validation toxicity testing conducting, analyzing or Marketing Hit identification In vitro studies (cell reporting clinical authorization culture) trials Lead optimization In vivo studies Quality Assurance (animal models) Laboratory or central services (e.g. imaging, ECG reading)
Traning/Consulting
eSolutions
Source: BIOCOM
8 Contract Research Organizations | health-made-in-germany.com ery field is the advent of stem cell technologies increasingly rich pool of biomedical and patient such as cellular reprogramming. This method data – including genomic, proteomic, microbi- allows adult human cells to be converted into ome and biomarker data – to tap into, CROs induced pluripotent stem cells (iPS cells). iPS active in clinical development have invested cells are a resource to generate any cell type of heavily in data technology and powerful IT the human body. They enable the generation of system infrastructure. Collection and analysis of cell-based disease models. Biotech companies high-quality data is considered as being key to in Germany have expanded their drug screening effective drug development processes. One area Germany is activities in the stem cell field on a large scale. in which such data outputs are extremely valu- renowned for its able is real world data and real world evidence clincial research – Clinical CRO landscape studies. When combined with big data, artificial clinical CROs Internationally, Germany is renowned for its intelligence and machine learning algorithms offer specialized excellent academic and clinical research. It is have the potential to greatly improve the clini- services for this also one of Europe’s leading countries in terms cal trial process. Another very successful niche phase of drug of the number of clinical studies conducted. German CROs occupy are eSolutions including development. Clinical CROs organize and manage clinical stud- the use of social media in patient recruitment or ies from phase I to phase III and secure clinical data management and statistical tools. trial monitoring, thereby delivering the much- needed information basis required for approval. This guide illustrates the diversity, strength and A number of central laboratories offer the full depth of the German contract research landscape. range of laboratory services in clinical research. We hope that it will be of assistance in helping Conducting phase I clinical studies is a particular you identify the services and expertise needed strength of clinical CROs in Germany. With an for your own successful drug development.
9 COMPANY PROFILES Find your German partner Our directory lists contract researchers and their respective fields of activity as well as services and technologies offered. Company and technology overview The table below gives an overview of the listed companies and their fields of activity Company Synthesis & Analysis Characterisation Bio- / Chemoinformatics Screening Medical Chemistry & Delivery Galenics Pharmacodynamics, -kinetics Cell Culture Technology Bioanalytics Diagnostic Services Clinical Research
8sens.biognostic GmbH
ABX-CRO advanced pharmaceutical services
Accelero® Bioanalytics GmbH
acromion GmbH
Alcedis GmbH
Allied Clinical Management GmbH
AMP-Lab GmbH
AMS Advanced Medical Services
analyze & realize GmbH
Antiinfectives Intelligence GmbH
ARTES Biotechnology GmbH
ASCA GmbH Angewandte Synthesechemie Adlershof
Assay.Works GmbH
ATLAS Biolabs GmbH
Axolabs GmbH
AZ Biopharm GmbH Berlin
Biaffin GmbH & Co KG
Bicoll GmbH
Bioassay GmbH
biometec GmbH
Biosyntan
BIOTREND CHEMIKALIEN GmbH
Carpegen GmbH
CeGaT GmbH
Celares GmbH
cellasys GmbH
CellServe GmbH
CellTrend GmbH
11 Company and technology overview The table below gives an overview of the listed companies and their fields of activity Company Synthesis & Analysis Characterisation Bio- / Chemoinformatics Screening Medical Chemistry & Delivery Galenics Pharmacodynamics, -kinetics Cell Culture Technology Bioanalytics Diagnostic Services Clinical Research
ChemCon GmbH
Chimera Biotec GmbH
CIRES cell & immune research services
CONET GmbH
Conreso GmbH
Coriolis Pharma Research GmbH
CROLLL GmbH
CRS Clinical Research Services Andernach GmbH
CTC North GmbH & Co. KG
Cube Biotech GmbH
Dr. Notghi Contract Research GmbH
Dr. Regenold GmbH
emovis GmbH
ENDOTHERM GmbH
Evotec SE
eXcorLab GmbH
Experimentelle Pharmakologie & Onkologie Berlin-Buch GmbH
FGK Clinical Research GmbH
Formula GmbH
GALAB Technologies GmbH
GBA Group Pharma
GKM Gesellschaft für Therapieforschung mbH
glyXera GmbH
Health Research Services GmbH
Heidelberg Pharma AG
ICCR-Roßdorf GmbH
Immundiagnostik AG
INFAI
12 Contract Research Organizations | health-made-in-germany.com Company and technology overview The table below gives an overview of the listed companies and their fields of activity Company Synthesis & Analysis Characterisation Bio- / Chemoinformatics Screening Medical Chemistry & Delivery Galenics Pharmacodynamics, -kinetics Cell Culture Technology Bioanalytics Diagnostic Services Clinical Research
Insilico Biotechnology AG
Institut für Atemwegsforschung (INSAF) GmbH
IQVIA RDS GmbH
JPT Peptide Technologies GmbH
KOEHLER eClinical GmbH
LEUKOCARE AG
Life & Brain GmbH
Lionex GmbH
Lipotype GmbH
Mediagnost GmbH
Mediconomics GmbH
MEDICRO GmbH
menal GmbH
Merck Chemicals GmbH
metabion GmbH
Metronomia Clinical Research GmbH
micro-biolytics GmbH
Microcoat Biotechnologie GmbH
MicroDiscovery GmbH
MicroMol GmbH
Micromun
Minerva Analytix GmbH
MLM Medical Labs GmbH
OakLabs GmbH
OmicScouts GmbH
OmniComm Europe GmbH
PEPperPRINT GmbH
peptides&elephants GmbH
13 Company and technology overview The table below gives an overview of the listed companies and their fields of activity Company Synthesis & Analysis Characterisation Bio- / Chemoinformatics Screening Medical Chemistry & Delivery Galenics Pharmacodynamics, -kinetics Cell Culture Technology Bioanalytics Diagnostic Services Clinical Research
PharmaInformatic
PHARMALOG Institut für klinische Forschung GmbH
PortaCellTec biosciences GmbH
preclinics Gesellschaft für präklinische Forschung mbH
Premier Research
PRIMACYT Cell Culture Technology GmbH
proDERM
Profil Germany GmbH
ProJect Pharmaceutics GmbH
Prolytic GmbH
Proteome Factory AG
PXBioVisioN GmbH
SanaClis DE GmbH
SequentiX - Digital DNA Processing
Seramun Diagnostica GmbH
Sirius Fine Chemicals SiChem GmbH
SSS International Clinical Research GmbH
StarSEQ GmbH
SynapCon Ltd.
SYNLAB Analytics & Services Germany GmbH
Taros Chemicals GmbH & Co. KG
TherapySelect Dr. Frank Kischkel
TRIGA-S Scientific Solutions
vertis Biotechnologie AG
Vibalogics GmbH
VivaCell Biotechnology GmbH
Winicker Norimed GmbH
Zentrum für Humangenetik und Laboratoriumsdiagnostik
14 Contract Research Organizations | health-made-in-germany.com 15 company profiles
8sens.biognostic GmbH
Robert-Rössle-Straße 10 Founded: 2000 13125 Berlin Employees: 12 T +49 (30) 9489-2116 [email protected] F +49 (30) 9489-2117 www.biognostic.de
Target Discovery 8sens.biognostic GmbH know-how. Target Validation • Development of Immunochromatographic We offer: Hit Identification Rapid Tests – complementing laboratoy analy- • realisation of complete R&D projects on demand Lead Optimisation ses or even making them obsolete • stages include: Preclinical Studies • Easy access to fast growing point-of-care mar- • feasibility studies Clinical Trials ket – not only for ELISA-developers • test development • declaration of conformities Our application fields: healthcare: human, den- • production of entire test systems tal and veterinary medicine, food industry, drug • different sample matrices control, environmental • CE-, ISO- and IVDR-compliant • cost-efficient & transparent milestone de- 8sens.biognostic has ample experience in trans- pendent project work and payment schedules fering your know-how to lateral flow test strips. • certified production facilities in Berlin, Germany On request, we will develop the entire test for you – consumer-ready from research & devel- opment to production. Take advantage of our
ABX-CRO advanced pharmaceutical services
Blasewitzer Straße 78–80 Founded: 2002 01307 Dresden Employees: 80 T +49 (351) 2144-40 [email protected] F +49 (351) 2144-415 www2.abx-cro.com
Target Discovery ABX-CRO is a globally operating clinical research We translate pre-clinical results into First in Target Validation organization with a strong focus on pre-clinical Man studies and support you with design and Hit Identification and clinical molecular imaging and molecular ra- execution of efficient late stage clinical trials, Lead Optimisation diotherapy. Based on over 15 years of experience minimizing your costs and time to marketing Preclinical Studies in diagnostic and therapeutic oncology, neurol- authorization. ABX-CRO makes translational Clinical Trials ogy and other disease areas, ABX-CRO provides medicine a visible reality. you with unique opportunities to test your drug candidates in complex pre-clinical disease mod- els which can be assessed quantitatively using molecular and functional imaging (PET, SPECT, CT, MRI).
16 Company Directory 2020 | health-made-in-germany.com Accelero® Bioanalytics GmbH accelerō bioanalytics
Volmerstraße 9A Founded: 2011 12489 Berlin Employees: 9 T +49 (30) 610-910-307 [email protected] www.accelero-bioanalytics.com, www.binding-assay.com
Accelero Bioanalytics is a laboratory service Benefit from our everyday practice and visit one Target Discovery provider: of our GLP seminars, or contract us for an GLP Target Validation • Good Laboratory Practice (GLP) certified audit at your site! Hit Identification • Good Clinical Practice (GCP) compliant Lead Optimisation • Biosafety level 3** for potentially infectious Preclinical Studies material Clinical Trials • Genetic engineering safety level 2 approved
Our expertise includes Advanced Therapy Me- dicinal Products (ATMP) like: • Living biotherapeutics (microbial cells, human mesenchymal cells, limbal stem cells, etc) • Adeno-associated viruses (AAV) • Adenovirus serotype 5 oncolytic viruses (replicative and non-replicative)
acromion GmbH
Europaallee 27–29 Founded: 2002 20226 Frechen Employees: 47 T +49 (2234) 2037-370 [email protected] F +49 (2234) 2037-379 www.acromion-gmbh.com
acromion GmbH is a German headquartered, A good match: acromion is the right sized Target Discovery privately owned, full-service, clinical Contract research partner that integrates professional Target Validation Research Organisation. expertise aiming at the most suitable trial Hit Identification design, plan and conduct. We can introduce the Lead Optimisation Operating throughout Europe, our teams pro- right team to fit your company’s needs and the Preclinical Studies vide the full range of clinical research services specifics of your project; skilled, experienced, Clinical Trials for biotech, pharmaceutical, medical device and flexible. diagnostics industries. Full or part service: protocol development or Founded in Germany in 2002, our company now validation, hands-on project management, site offers nearly two decades of successful clinical recruitment, study start-up including regulatory research across all stages of clinical drug devel- management in geographical Europe, clinical mon- opment, starting at First-in-Man to postmarket- itoring, data management, EDC, STDM, biostatis- ing studies and registries. Our work has been tics, safety management and pharmacovigilance, successfully audited by numerous clients and medical writing (protocol, ICF, IB, IMPD, CSR, CTD, inspected by competent authorities. publications), site training, quality assurance.
17 company profiles
Alcedis GmbH
Winchesterstraße 3 Founded: 1992 35394 Gießen Employees: 120 T +49 (641) 94436-0 [email protected] F +49 (641) 94436-70 www.alcedis.de
Target Discovery Alcedis GmbH stands for long years of CRO ex- Classical CRO services provided are Scientific Target Validation perience and profound expertise in the conduct Consulting, Clinical Project Management, Moni- Hit Identification of clinical trials. One focal point distinguishing toring, Medical Writing, Regulatory, Data Man- Lead Optimisation Alcedis is our innovative software AlcedisTRIAL agement, Pharmacovigilance and Biometrics. Preclinical Studies that constitutes a centrepiece of the Alcedis Clinical Trials trademark. Our module-based service concept adjusts itself flexibly to your project structure. Likewise With our offices in Gießen, Hamburg and New individually adapted are our data entry and York we offer a full service portfolio and suc- software systems. cessfully conduct phase (I), II–IV clinical studies as well as non-interventional studies in various indications on a global platform.
Allied Clinical Management GmbH
Hamburger Straße 14 Founded: 2004 16341 Panketal Employees: n.a. T +49 (30) 240 4788-0 [email protected] F +49 (30) 240 4788-19 www.allied-clinical.com
Target Discovery Since its founding in 2004, Allied Clinical Man- • Monitoring and Site Management Target Validation agement GmbH has been conducting medical • Ethics Committee and Competent Authority Hit Identification device and pharmaceutical product clinical trials dossier preparation according to GCP, ISO and Lead Optimisation ethically, reliably and efficiently. national and international regulations Preclinical Studies • Data Management Clinical Trials A commitment to long term partnerships with • Biostatistics sponsors enables it to deliver clinical data of • Medical Writing and Publication superior and consistent quality. • Pharmacovigilance and Device Vigilance • Regulatory Affairs As a member of the MEDIS RESEARCH GROUP, • Authorized Representative for Companies Allied Clinical Management provides the follow- outside the EU ing services for prospective clinical trials: • Marketing Applications • Planning and Designing of Translational Stud- ies and Clinical Trials • Scientific Consulting • Trial Management
18 Company Directory 2020 | health-made-in-germany.com AMP-Lab GmbH
Mendelstraße 11 Founded: 1998 48149 Münster Employees: 4 T +49 (6131) 26345-70 [email protected] F +49 (6131) 3354-22 www.amplab.de
AMP-Lab is an independent laboratory for Our laboratory is fully equipped for physi- Target Discovery applied biological research in physiology and ological and biochemical analyses. Our close Target Validation biochemistry. cooperation with institutes for physiological Hit Identification and biochemical research is a guarantee of our Lead Optimisation Our expertise and facilities meet special services up-to-date knowledge and techniques. Preclinical Studies and products, currently available on five differ- Clinical Trials ent levels of physiology: • enzymes, • metabolism, • physiological liquids, • semen analysis • and angiogenesis.
We consult in individual questions on physiology. For solving your particular problem, time-limited research programs are offered on your request.
AMS Advanced Medical Services
Am Exerzierplatz 2 Founded: 1997 68167 Mannheim Employees: 300 T +49 (621) 70095-100 [email protected] F +49 (621) 70095-140 www.ams-europe.com
AMS established itself as reliable service pro- to bring your project to fruition. Our Team is Target Discovery vider for Clinical Research and Sales Force Serv- characterized by the continuous interaction of Target Validation ices. To realize your goals, we work to develop experts in Medical Writing, Biostatistics and Hit Identification a common understanding of the objectives and Public Health Economics. Based on our long- Lead Optimisation the paths that will lead us to achieve them. We term experience in the fields of global clinical Preclinical Studies thus strive to align the perspective of our cus- development, drug registration, benefit assess- Clinical Trials tomers with the knowledge of our experts. ment, price negotiations and reimbursement, we Full support service in Clinical Research including make it our mission to implement your goals. post-marketing services with global reach: Whatever the task, you can have total confidence AMS offers field force solutions in DACH: build- in AMS Clinical Research. The experience, ing up and allocating field sales forces, filling solution-oriented and flexible thinking of AMS’ vacancies via employee assignments and online teams will stand out from the crowd. certification courses.
In close exchange with the HTA authorities, we Take advantage of our expertise and our enthu- are at the forefront of current developments siasm for new challenges!
19 company profiles
analyze & realize GmbH
Waldseeweg 6 Founded: 1993 13467 Berlin Employees: 40 T +49 (30) 4000-8100 [email protected] F +49 (30) 4000-8500 www.analyze-realize.com
Target Discovery analyze & realize – Your innovation experts Consulting & Strategic Innovation Target Validation in natural health products. Our services range from regulatory consulting to Hit Identification The company was founded in 2000 and offers product development for food and supplements Lead Optimisation consultancy and clinical research services to the (incl. novel food and health claim strategies) and Preclinical Studies consumer health and natural products sector. as well for herbal drugs and substance-based Clinical Trials Our services are closely aligned with the current medical devices. market situation for the respective products. Hence, our professional support is guided by in- MatchMaking ternational and national trends that are defined Our unique expertise and more than 20 years of by regulations and consumer needs. international networking in the natural products industry allow us to identify relevant in- and Clinical Research out-licensing opportunities and assist in the Clients can profit from our experience in more selection of the optimal partners to grow our than 300 clinical trials with natural health clients business. products and our in-depth expertise in the de- velopment of targeted study designs reflecting individual needs.
Antiinfectives Intelligence GmbH
Von-Liebig-Straße 20 Founded: 2000 53359 Rheinbach Employees: 8 T +49 (2226) 908-911 [email protected] F +49 (2226) 908-918 www.antiinfectives-intelligence.de
Target Discovery We carry out microbiological research: • Investigations of the development of the Target Validation Microbiological safety: resistance of bacteria to antibiotics resistance Hit Identification • Testing of the efficacy of preservatives used in surveillance studies Lead Optimisation pharmaceuticalss • Planning, organization, carrying out and Preclinical Studies • Testing of the microbiological quality of evaluation of resistance surveillance studies Clinical Trials medications with and without preservativess • Preparation of final reports and publications • Testing of the microbiological safety of of external resistance surveillance studies medicinal productss • Investigation of the microbiological stability of products (shelf life) during simulation models In-vitro Activity of Antibiotics • Determination of the in-vitro efficacy of antibiotics • Determination of the pharmacodynamics of antibiotics in an in-vitro models
20 Company Directory 2020 | health-made-in-germany.com ARTES Biotechnology GmbH
Elisabeth-Selbert-Straße 9 Founded: 2002 40764 Langenfeld Employees: 22 T +49 (2173) 275 870 [email protected] F +49 (2173) 275 8777 www.artes-biotechnology.com
ARTES Biotechnology is a biopharmaceuti- In addition to genetic engineering, the company Target Discovery cal contract research organization (CRO) that provides fermentation and downstream process Target Validation provides microbial cell line and process devel- development, analytical assay development and Hit Identification opment for bio-pharmaceutical products. The production cell line characterization. Lead Optimisation company is a well-established partner for many Preclinical Studies of the biggest names in the industry, with more ARTES operates worldwide from its 850 m2 S1 Clinical Trials than 20 years of business experience, a track facilities in Langenfeld, Germany, from where record of products developed for and marketed it also supplies non-GMP bulk material (API) by clients as well as for safe, reliable and highly for activity and toxicity tests and technology competitive microbial production platforms. transfer to cGMP facilities and scale-up support.
ARTES specializes in recombinant protein produc- Further information from the ARTES Biotechnol- tion, process and vaccine development, market- ogy website at: www.artes-biotechnology.com ing the unique METAVAX® (dHepB-VLP) technol- ogy in combination with yeast expression.
ASCA GmbH Angewandte Synthesechemie Adlershof
Magnusstr. 11 Founded: 2000 12489 Berlin Employees: 16 T +49 (30) 6392-2070 [email protected] F +49 (30) 6392-4103 www.asca-berlin.de
ASCA provides the pharmaceutical industry, Our catalogue comprises mor than 400 com- Target Discovery crop protection and biotech companies with a pounds and relevant metabolites. Target Validation partner for the synthesis and optimisation of Hit Identification lead structures. We supply novel and practicable Categories are: Lead Optimisation solutions for the development of new active • pesticides Preclinical Studies structures, and check these on a laboratory • API’s Clinical Trials scale. • plastc additives like sun blockers • mycotoxines ASCA offers an extension of our partners’ • drug-like natural products. preclinical research capacity. The cooperation is caracterized by close contact and regular We also offer custom syntheses. progress reports.
Furthermore we are well experienced in the preparation of reference substances and labelled analytical standards.
21 company profiles
Assay.Works GmbH
Am Biopark 11 Founded: 2016 93053 Regensburg Employees: 6 T +49 (941) 2000-1240 [email protected] F +49 (941) 2000-1241 www.assay.works
Target Discovery Assay.Works is a contract research organization Our service portfolio includes: Target Validation (CRO) providing research services to pharmaceu- • Assay Development Hit Identification tical/biotech companies and academic organiza- • High-Throughput Screening (HTS) Lead Optimisation tions in form of fee-for-service work. • Cell Line Engineering and Production of Preclinical Studies Cellular Reagents Clinical Trials Our mission is to accelerate our partner’s • Bioactivity Assessments research programs by developing and execut- • Quantitative Biology Applications ing predictive and scalable assays to quantify the bioactivity of novel chemical and biological entities. We combine scientific rigor with our domain expertise in laboratory automation, informatics, and industry best practices to turn challenging assays into quantitative, reproduc- ible results.
ATLAS Biolabs GmbH
Friedrichstraße 147 Founded: 2006 10117 Berlin Employees: 15 T +49 (30) 3198966-0 [email protected] F +49 (30) 3198966-19 www.atlas-biolabs.com
Target Discovery ATLAS Biolabs is a leading European service pro- It has great experience to manage large projects. Target Validation vider of complex analyses in molecular genetics, We can guarantee GCP compliance, as our labo- Hit Identification including next generation sequencing, microar- ratory staff has been trained on GCP and we Lead Optimisation ray analyses supplemented by high-level data are following guidelines of the Medicines and Preclinical Studies analyses support and RNA/DNA isolation from Healthcare products Regulatory Agency (MHRA). Clinical Trials biological specimens. ATLAS fulfills the requirements for design and manufacturing in vitro diagnostic medical Founded in 2006 as a spin-off of the German devices according to ISO 13485:2012/AC:2012. Resource Center for Genomics and the Cologne Quality management is organized according to Center for Genomics. Company’s services are ISO 9001:2008. certified by Affymetrix, Agilent, and NimbleGen. Customers include academic institutions, phar- maceutical and biotechnological companies as well as clinicians and registered doctors.
22 Company Directory 2020 | health-made-in-germany.com Axolabs GmbH
Fritz-Hornschuch-Straße 9 Founded: 2000 95326 Kulmbach Employees: 95 T +49 (9221) 8276-28115 [email protected] F +49 (9221) 8276-299 www.axolabs.com
Axolabs is the leading Custom Research Organi- Our products and services relating to oligonu- Target Discovery zation focused on the discovery and preclinical cleotides include manufacturing, analytics and Target Validation drug development in the field of oligonucleotide detection, also including mRNAs, from biological Hit Identification therapeutics and nucleic acid medicines. matrices under the standards of GLP/GCP, lead Lead Optimisation identification, functional cell type-specific deliv- Preclinical Studies With our world-leading know-how we provide ery, a variety of biological and pharmacological Clinical Trials high-end preclinical solutions and consultancy techniques, as well as release under GMP. tailored to our clients’ specific needs.
AZ Biopharm GmbH Berlin
Bitterfelder Straße 19 Founded: 2002 12681 Berlin Employees: 29 T +49 (30) 93652-0 [email protected] F +49 (30) 93652-200 www.az-biopharm.de
Analytical Center Biopharm GmbH is a GLP and AZB is actively working on the development and Target Discovery GMP certified testing facility (CRO) with many validation of new, analytical methods that are Target Validation years of experience in bioanalytical and pharma- required among others as part of an authorisa- Hit Identification ceutical testing of human and veterinary drugs. tion and registration obligation in the pharam- Lead Optimisation ceutical industry. Compliance with the applica- Preclinical Studies We determine the identity, content and purity ble and valid guidelines (EMA, FDA, ICH, VICH, Clinical Trials of active substances and drug products and etc.) is a top priority in this process. Within perform residue analysis in edible farm animal bioanalysis, AZB develops and validates new tissues, stability testing and physicochemi- methods for pharmaceutical active ingredients cal analysis of intermediates according to the and their metabolites as well. Chemicals Act. Under GLP and/or GCP we determine the drug concentration and, where AZB is characterized by flexibility and innova- applicable, their metabolites in biological matrix tivity and has been a reliable partner of the in bioequivalence-, pharmacokinetic-, bioavail- pharma industry for 25 years. ability- and preclinical studies using state-of- the-art analytical techniques.
23 company profiles
Biaffin GmbH & Co KG – Biomolecular Interaction Analysis
AVZ 2, Heinrich-Plett-Straße 40 Founded: 2001 34132 Kassel Employees: 7 T +49 (561) 8044 668 [email protected] F +49 (561) 8044 665 www.biaffin.com
Target Discovery Biaffin is an ISO 9001 certified company offering batch to batch comparison of therapeutic anti- Target Validation services in biomolecular interaction analysis bodies, biologics and biosimilars. SPR studies on Hit Identification with expertise and knowledge in application of specificity, selectivity, mechanism of action and Lead Optimisation biosensors based on surface plasmon resonance thermodynamics are performed as well. Preclinical Studies (SPR) to kinetically characterize any pair of in- Clinical Trials teracting molecules in real-time. Well equipped Besides SPR services Biaffin offers biochemi- with several SPR Biacore instruments Biaffin as- cal assays based on microfluidic mobility shift sures performance of projects in a professional technology (MMSA) and bioluminescence. and timely manner.
Biaffin’s SPR services are applied in various stag- es of drug development like fragment-based and confirmatory, secondary screening, hit validation, lead optimization and ADME studies. In biopharmaceutical development Biaffin offers kinetic characterization, stability analyses and
Bicoll GmbH
Am Klopferspitz 19 Founded: 2000 82152 Planegg/Martinsried Employees: 5 T +49 (89) 820 106 30 [email protected] F +49 (89) 529 178 www.bicoll-group.com
Target Discovery Bicoll is an expert in field of plant small mole- biological screening approaches (whole cell, Target Validation cules backed up by a strong medicinal chemistry. whole organism) as well as biochemical high- Hit Identification Bicoll focuses on delivering breakthrough solu- throughput-screening set-ups (e.g. protein-pro- Lead Optimisation tions in pharmaceuticals, cosmetics, nutraceuti- tein interaction with FRET-read-out). Preclinical Studies cals and agriculture. Clinical Trials With further innovative strategies supported by Bicoll is an inventor of Bicoll Plant Profiles™, its proprietary in-house technology platform, which provides the fastest and the most suc- BICOLL is able to rapidly select only the best cessful method from initial screening to the leads with superior drug-like profiles for the animal tests or products. Bicoll offers solutions further development cycles. from scientific gathered and carefully processed plant species with an outstanding knowledge in high tech natural product chemistry to validated experience in medicinal chemistry to any type of client: from big pharma to a small research group. The robust technology allows it to serve
24 Company Directory 2020 | health-made-in-germany.com Bioassay GmbH
Im Neuenheimer Feld 515 Founded: 2002 69120 Heidelberg Employees: 25 T +49 (6221) 43388-910 [email protected] F +49 (6221) 43388-99 www.bioassay-online.de
Bioassay GmbH is an independent contract Our portfolio contains 4 focus areas: Target Discovery laboratory, specializing in the development, • BioPharma Potency Target Validation validation and routine performance of bioana- • BioPharma Efficacy Hit Identification lytical assays in the area of Pharmacology and • BioPharma Safety Lead Optimisation Toxicology. • Chemicals/Cosmetics Safety Preclinical Studies Clinical Trials We carry out qualified analytical services on In our in-vivo and in-vitro facilities we are the sound basis of our GMP & GLP certification, running state-of-the-art-equipment and our which provides an excellent framework for suc- analytical experts will welcome you to visit us in cessful projects and routine bioanalysis. our laboratories located directly in the Heidel- berg Technology Park (Germany). Bioassay GmbH is specialized in the develop- ment, validation and execution of biological assays within the framework of Development & Quality Control of pharmaceutical and chemical products.
biometec GmbH
Walther-Rathenau-Straße 49a Founded: 1992 17489 Greifswald Employees: 2 T +49 (3834) 515-620 [email protected] F +49 (3834) 515-622 www.biometec.de
The company is engaged in the development, Our service include Hybridoma development Target Discovery production and distribution of research products for new antibody producing cells, monoclonal Target Validation for infection biology especially CD14, LBP and antibody production, purification and label- Hit Identification antibodies. In addition biometec offers a variety ling as well as contract research as cell culture Lead Optimisation of laboratory and immunbiological services for investigations, animal models, cytokine research, Preclinical Studies academic institutes as well as pharmaceutical microbiological investigations, immunological Clinical Trials and biotechnological companies. contract research, screening investigations for clinical studies, polyclonal antibody service and ELISA development.
25 company profiles
Biosyntan
Robert-Rössle-Straße 10 Founded: 1997 13125 Berlin Employees: 6 T +49 (30) 9489 3498 [email protected] F +49 (30) 9489 3497 www.biosyntan.de
Target Discovery BIOSYNTAN GmbH was founded in 1997 as a Our core area is the manufacturing of fluores- Target Validation scientific service company, focused on custom cently labeled peptides for assay development Hit Identification synthesis of peptides. A rising interest of our and the synthesis of posttranslational modified Lead Optimisation costumers in modified peptides has prompted peptides. Preclinical Studies us to develop new methods for the manufactur- Clinical Trials ing of such compounds.
As one of the leading specialists in the synthe- sis of linear and cyclic peptides with unusual residues (natural or artificial) and a multitude of modifications we can offer you an extensive range of services today.
BIOTREND CHEMIKALIEN GmbH
Eupener Straße 157 Founded: 1988 50935 Köln Employees: 14 T +49 (221) 94983-20 [email protected] F +49 (221) 94983-25 www.biotrend.com
Target Discovery After more than a decade of experience in the distribution facility offering high quality, yet Target Validation sale and marketing of research products for cost-effective products for biochemical, immun- Hit Identification “Life Science Research”, Werner Hassler, Switzer- ochemical and pharmaceutical research, offering Lead Optimisation land and Gunther Jaeger, Germany founded the Conjugation Service, Custom Antibody Produc- Preclinical Studies Cologne based BIOTREND Chemikalien GmbH in tion, Peptide Libraries and Peptide Syntheses, Clinical Trials May 1988. [125I] Iodination Service, [3H] Tritiation Service.
BIOTREND was instigated in order to meet the growing demand from customers for an independent and technologically orientated
26 Company Directory 2020 | health-made-in-germany.com Carpegen GmbH
Mendelstraße 11 Founded: 2001 48149 Münster Employees: 8 T +49 (251) 980 2320 [email protected] F +49 (251) 980 2321 www.carpegen.de
Carpegen is a provider of high quality molecular A main objective of Carpegen’s research pro- Target Discovery diagnostics. The company focuses on developing gram is to develop and out-license POC/PCR Target Validation real-time PCR assays and point-of-care (POC) di- systems for diverse applications in human and Hit Identification agnostics for the diagnosis of specific infections veterinary medicine, as well as in food/beverage Lead Optimisation and the detection of genetic biomarkers. and environmental analytics. Preclinical Studies Clinical Trials Carpegen has developed Carpegen® Perio Diag- A joint R&D project related to the development nostics, a powerful real-time PCR based system of innovative analytics of water pathogens is that sets new standards in microbiological peri- currently being pursued with financial support odontal diagnostics. of the German Federal Ministry for Economic Affairs and Energy.
CeGaT GmbH
Paul-Ehrlich-Straße 23 Founded: 2009 72076 Tübingen Employees: 170 T +49 (7071) 565 4455 [email protected] F +49 (7071) 565 4456 www.cegat.de
CeGaT is a global provider of genetic diagnos- Moreover, we provide a variety of sequencing Target Discovery tics and mutation-related disease analyses. Our services. These include not only the prepara- Target Validation laboratory is located in Tuebingen, Germany and tion of the samples using various automated Hit Identification is fully accredited with a focus on high quality platforms, but also Next-Generation Sequenc- Lead Optimisation results (CAP/CLIA and ISO 15189:2014). ing (NGS) on different platforms (NovaSeq and Preclinical Studies MiSeq). Clinical Trials Our diagnostics product portfolio includes diagnostic panels, single gene testing, exome di- We can provide additional data analysis options, agnostics, deletion/duplication analyses, array- with the choice to receive raw sequencing data CGH, tumor diagnostics and many more. through to processed and filtered variant call files.
27 company profiles
Celares GmbH
Building D80, Robert-Rössle-Straße 10 Founded: 2003 13125 Berlin Employees: 20 T +49 (30) 9489 2350 [email protected] F +49 (30) 9489 2351 www.celares.com
Target Discovery The conjugation of drug molecules is an estab- of purification and analytical methods, consist- Target Validation lished tool for increasing tolerance, efficacy, ency runs, generation of reference standards, Hit Identification half-life, or solubility of (bio)pharmaceuticals. stability studies according to ICH Contract Lead Optimisation Celares has an unique expertise in PEGyla- manufacturing of activated PEGs, PEG-drug Preclinical Studies tion/conjugation of (bio)molecules and offers conjugates and small molecule drugs – Proof-of- Clinical Trials customized solutions for conjugation of (bio) concept material, production of activated PEGs molecules as well as process development and based on GMP, tailor-made PEGs or other poly- contract manufacturing. mers, such as block-copolymers, hyperbranched polyglycerols, among others. Our services include feasibility studies – investi- gation of conjugation strategies, ADC-strategies, Celares also offers surface modification tech- screening of different conjugation reagents, nologies for diagnostic purposes. preparation and characterization of drug-conju- gate test samples – development services from scratch to the clinical phase – optimization of reaction conditions, development and validation
cellasys GmbH
Illerstraße 14 Founded: 2007 87758 Kronburg Employees: 1 T +49 (8394) 257929 [email protected] www.cellasys.com
Target Discovery cellasys delivers system solutions for microphys- The measurement is label-free, parallel, continu- Target Validation iometry. These include services such as contract ous and in real-time. With our BioChip technol- Hit Identification research, research & development, and produc- ogy one can e.g. determine the efficacy of a Lead Optimisation tion & maintenance. drug outside of humans (or animals) directly on Preclinical Studies living cells. Clinical Trials Furthermore we offer consulting services in the area of application development, data analysis and data interpretation.
The microphysiometric systems monitor differ- ent parameters directly from living cells. These parameters include extracellular acidification
(pH), cellular respiration (pO2) and morphology (impedance).
28 Company Directory 2020 | health-made-in-germany.com CellServe GmbH
Chariteplatz 1 Founded: 1996 10117 Berlin Employees: 1 T +49 (30) 4505-13198 [email protected] F +49 (30) 4505-13943 www.cellserve.de
CellServe GmbH is a spin-off of Charité – Uni- The study protocol for the clinical Phase I/II Target Discovery versity Medicine, Berlin-Brandenburg Center for trial has been finalized and is approved by the Target Validation Regenerative Medicine (BCRT). responsible ethics committee of Berlin and Paul- Hit Identification Ehrlich Institute (PEI). Lead Optimisation CellServe GmbH is developing a cell therapy for Preclinical Studies the treatment of life-threatening chronic heart Clinical Trials disease.
The cell product, consisting of Cardiac- derived Adherent Proliferation Cells, shows excellent cardiac function improvement in preclinical studies, but also provides the practical prerequisites for the preparation of a commercial cell therapy.
CellTrend GmbH
Im Biotechnologiepark Founded: 1998 14943 Luckenwalde Employees: 7 T +49 (3371) 6199 600 [email protected] F +49 (3371) 6199 604 www.celltrend.de
CellTrend is an innovative certified (GMP, ISO • Contract analytical service for preclinical and Target Discovery 13485) biotech company. We offer the following clinical samples Target Validation technologies and services: • Development, production and distribution of Hit Identification immunoassays for diagnostic and research Lead Optimisation Cell culture assays for drug research Preclinical Studies (bioactivity assays): Consulting Clinical Trials • Screening • External qualified person • Lead optimization • Quality Management Systems • drug development • GMP testing lab for bioanalytical methods
Immunoassays • Development of assays for new analytes, immunogenicity testing • Development of Companion Diagnostics
29 company profiles
ChemCon GmbH
Engesserstraße 4b Founded: 1997 79108 Freiburg Employees: 100 T +49 (761) 5597 0 [email protected] F +49 (761) 5597 449 www.chemcon.com
Target Discovery ChemCon is a GMP-compliant contract develop- Besides APIs, ChemCon also offers the synthesis Target Validation ment and manufacturing organization (CDMO) of other compounds, such as advanced excipients, Hit Identification and provider of analytical testing services. injectable-grade trace elements, delivery agents, Lead Optimisation Customers worldwide use ChemCon’s services to or reference standards to your specifications. Preclinical Studies source high-quality APIs for clinical trials, regis- Clinical Trials tration and/or commercial applications. ChemCon’s high-quality/small-to-medium- quantity niche can be particularly interesting ChemCon’s FDA-inspected facilities are opti- for applications in orphan diseases, oncology, mized for the chemical production of small to emergency care, transfection (synthesis of the medium quantities (grams to a few hundred polymer), and other specialty applications. Com- kilograms annual supply) of GMP material for prehensive in-house analytics, stability studies, human use. With multidisciplinary chemical documentation, and regulatory support com- expertise, ChemCon meets your individual de- plete our services. mands for small-molecule organic APIs, inorgan- ic salts and complexes, or polymers, including ChemCon looks back on an outstanding inspec- highly potent or controlled substances. tion history both by the FDA and European health authorities.
Chimera Biotec GmbH
Emil-Figge-Straße 76a Founded: 2000 44227 Dortmund Employees: 25 T +49 (231) 9742 840 [email protected] F +49 (231) 9742 844 www.chimera-biotec.com
Target Discovery Chimera Biotec provides ultra sensitive GLP/GCP Beside classical ELISA and other platforms we Target Validation bioanalytical support for all phases of drug dis- combine immunoassays with exponential PCR Hit Identification covery and development. For 20 years, we have read-out in Imperacer, our proprietary Immuno- Lead Optimisation specialized in supporting drug development PCR platform. Preclinical Studies programs with highest demands on bioanalyti- Clinical Trials cal quality. We can support studies where other CROs fail. Our research team is highly experienced in the Our long standing know how in beyond ELISA development and validation of ultra sensitive sensitive immunoassays enables us to make the immunoassays. most out of any immunoassay platform. All our services are conducted under strict qual- It is our goal to ensure your success in all phases ity regime and bioanalytical sample testing is of drug development providing highly sensitive, available for all needed regulatory demands, up accurate and reliable bioanalysis data on-time. to full GLP-compliant support.
30 Company Directory 2020 | health-made-in-germany.com CIRES cell & immune research services
Universitätsstraße 136 Founded: 2001 44799 Bochum Employees: 3 T +49 (234) 93696536 [email protected] F +49 (234) 93696538 www.cires.de
CIRES is a small Contract Research Company, 3. isolation of monoclonal IgG and IgM antibod- Target Discovery specialized on: ies by affinity chromatography or by DEAE Target Validation 1. generation of murine and rat Hybridomas, anion exchange chromatography Hit Identification We use special immunization procedures to Lead Optimisation get more monoclonal antibodies with higher 4. testing of adjuvants and immune stimulating Preclinical Studies specificities. agents Clinical Trials
One of our specialities is that we also get 5. application of innovative Cytokine-depot highly specific monoclonal antibodies against adjuvants developed by CIRES for various human antigens that show similarities to the vaccines corresponding murine antigens. 6. pre-clinical vaccine trials in mice. 2. mass production of monoclonal antibodies by bioreactor technology odf hybridoma cells
CONET GmbH – Clinical Operations Network
Amselstraße 25 Founded: 1998 68307 Mannheim Employees: 20 T +49 (621) 789 7000 [email protected] F +49 (621) 789 7010 www.conet-gmbh.de
CONET – Clinical Operations NETwork goal to provide Sponsors with the highest quality Target Discovery Your European Partner in Clinical Research servies. This committment is rooted in the corpo- Target Validation CONET’s Special Services: CONET is specialised rate value and is essential for CONET’s success. Hit Identification on immediate support for sponsors in case of Lead Optimisation challenging situations emerge: CONET GmbH, Clinical Operations Network, is a Preclinical Studies • Any concern about the performance of a clinical well established full service Contract Reserach Clinical Trials trial? Organization (CRO), headquartered in Mannheim • Any need to ensure clinical research data integrity? Germany. Since 1998 CONET operates with net- • Any need for resuce Monitoring in order to put work partners in Europe, US and Israel. CONET the trial back on track before it might be too late? offers flexible and customized solutions for clinical Trials Phase I–IV, pediatric trials, NIS, IITs In all these situations CONET is your preferred and clinical trials for medical devices for spon- partner to handle necessary activities like rescue- sors located in EU, US and Israel. monitoring, oversight- or co-monitoring, inspection readiness with expertise and extensive experi- For more information please contact us or see ence. CONET’s Quality Philosophy is driven by the www.conet-gmbh.de.
31 company profiles
Conreso GmbH
Neuhauser Straße 47 Founded: 1990 80331 München Employees: 20 T +49 (89) 2366-500 [email protected] F +49 (89) 2366-5050 www.conreso.com
Target Discovery Conreso, established in 1990, BVMA member, Further areas of particular expertise are onco- Target Validation offers a wide range of medical and clinical re- logical and vaccine studies. Quality and service Hit Identification search services, from phase II to late phase, epi- of Conreso are awarded by a constant repeat Lead Optimisation demiological and non-interventional studies as business rate of 90 %. Preclinical Studies well as other types of medica data collections. Clinical Trials The Conreso department of veterinary medicine Conreso shows an impressive record of success- provides all types of veterinary studies and data ful and significant contributions to important collections. new product licenses. Having recruited more than 30,000 patients between 0 and 17 years of Conreso has the permanent permission for pro- age proves the company’s unique expertise in viding temporary workers. pediatric trials.
Coriolis Pharma Research GmbH
Fraunhoferstraße 18 b Founded: 2008 82152 Martinsried Employees: 120 T +49 (89) 5424498-0 [email protected] F +49 (89) 5424498-22 www.coriolis-pharma.com
Target Discovery Coriolis is a globally operating service provider and manufacturability assessment • Support in con- Target Validation one of the world leaders in formulation research tainer closure system selection • In-use stabil- Hit Identification and development of (bio)pharmaceutical drugs ity studies • Stability testing including forced Lead Optimisation including proteins, peptides, monoclonal antibod- degradation studies • R&D and cGMP-compliant Preclinical Studies ies, RNA/DNA, virus-like particles, vaccines, ATMPs contract analytical services • Orthogonal analysis Clinical Trials and GMOs (up to Biosafety Level S2). of subvisible aggregates and particles • Testing of BSL1 and BSL2 GMO material • Polysorbate Coriolis is specialized in the provision of: analytics • Biosimilarity studies • Outstanding • Formulation development services for liquid scientific expertise and lyophilized products including BSL1 and BSL2 Our mission “Formulation Innovation”: combi- • Pre-formulation and candidate selection • Early nation of technologies, knowledge and experi- stage formulation development • Late phase for- ence to add substantial financial value to our mulation development • Lyophilization process customer’s projects by generating IP and sup- development • Lyophilization cycle optimization porting patent life cycle management in later • Scale-up and transfer studies • Developability/ phases.
32 Company Directory 2020 | health-made-in-germany.com CROLLL GmbH
Wörnitzstraße 115a Founded: 1998 90449 Nürnberg Employees: 38 T +49 (911) 252688 0 [email protected] F +49 (911) 252688 40 www.CROLLL.de
CROLLL, founded in 1998, is a full service CRO 800 projects have been completed successfully. Target Discovery offering design, conduct, monitoring and analysis Samples of our services are: Target Validation of clinical trials in cooperation with pharmaceuti- • Project management Hit Identification cal and medical devices industry, universities and • Trial coordination Lead Optimisation physicians. Our team of highly qualified employ- • Monitoring Preclinical Studies ees with long-term experience in clinical research • Co-monitoring/auditing Clinical Trials is focused on the rapid and straightforward • Regulatory affairs accomplishment of complete or partial solutions • Medical Writing for clinical trials as well as NIS and other research • Preparation of DSURs MedDRA and ATS/DDD projects. 20 successful years are based on our coding philosophy: individual – fast – flexible. We focus • Contract management on a very personalized service tailored to the • Preparation of scientific publications, presen- individual needs for the efficient conduct of all tations and posters projects. Our excellent quality of work is based • Literature research on the personal commitment and motivation of • Data management, eCRF and biometric serv- our employees in order to meet the ambitious ices in cooperation with vendors timelines of our clients. Up to now more than • Individual projects and challenges are welcome especially
CRS Clinical Research Services Andernach GmbH
Rennweg 72 Founded: 2006, foundation of legacy up to 1977 56626 Andernach Employees: 250 T +49 (30) 859949 401 [email protected] F +49 (30) 859949 222 www.crs-group.de
CRS is one of the leading Early Phase CROs Furthermore, a broad network of reliable part- Target Discovery in Europe with a broad expertise in clinical ners generates guaranteed access to patient Target Validation development from First in Man (FIM) to Proof areas, especially in cardiometabolic diseases, as Hit Identification of Concept (POC) studies in various patient well as renal & hepatic impairment. Lead Optimisation populations. Preclinical Studies The outstanding quality of CRS‘s services is Clinical Trials With a track record of more than 2,000 success- regularly confirmed by sponsor feedback, audits fully completed trials in more than 40 years of and authority inspections. Clients from vari- experience, CRS contributed to the development ous sectors of the healthcare industry (ranging and successful registration of numerous drugs in from large and small pharmaceutical & biotech various therapeutic indications. Operating four companies to developers of medical devices, Research units located in the main metropolitan nutritionals and cosmetics) benefit from the areas of Germany, CRS has reliable access to a comprehensive service portfolio offered by CRS. huge number of healthy volunteers and special patient populations.
33 company profiles
CTC North GmbH & Co. KG
Martinistraße 64 Founded: 2006 20251 Hamburg Employees: 70 T +49 (40) 5247-190 [email protected] www.ctc-north.com
Target Discovery Clinical Trial Center North (CTC North) is an inde- CTC North stands for complete clinical trial man- Target Validation pendent full service CRO located on the campus agement complying with a competent and fair Hit Identification of the University Medical Center Hamburg- feasibility assessment as well as a professional Lead Optimisation Eppendorf (UKE) – a perfect position to provide recruitment service (healthy trial volunteers or Preclinical Studies services in clinical research and development patients in particular indications). Clinical Trials and being an ideal partner for the pharmaceuti- cal, biotech and medical device industry. We offer advice and consulting services in the field of clinical research, particularly in the con- CTC North operates a state of the art Phase I duct of clinical trials. Regulatory submissions, unit with 35 beds (thereof 10 beds with inten- monitoring, data management, PK/statistics sive monitoring capabilities) plus 15 PSG beds and medical writing complete our full service for sleep studies, and conducts Phase I clinical approach. trials from “first-in-man” to “proof-of-concept” as well as phase II and III projects with 70+ highly qualified medical, scientific and regula- tory employees.
Cube Biotech GmbH
Alfred-Nobel-Straße 10 Founded: 2012 40789 Monheim Employees: 15 T +49 (2173) 99373 0 [email protected] F +49 (2173) 99373 99 www.cube-biotech.com
Target Discovery Cube Biotech is a privately-held company based ture determination, and are building long-term Target Validation in Monheim, Germany, with a fully-owned sub- partnerships to pharmaceutical, biotech, and Hit Identification sidiary in Wayne, PA, USA. academic organizations. Lead Optimisation Preclinical Studies Cube Biotech was founded in 2012 by a group We produce most of our service consumables at Clinical Trials of experts in membrane protein biology and our facilities in Germany, and sell these quality organic chemistry. With more than 50 years of products at reasonable pricing. In addition, we experience shared among us, we provide: have partnerships with renowned suppliers and • Excellence in membrane protein expression, are looking for OEM oppertunities from ml to purification, stabilization, and crystallization hundreds of liter scale. Whatever you find on • Expertise in synthesis of standard and tailor- our website follows the principle: “we use what made affinity matrices we sell, and we sell what we use”! • High-quality products at reasonable pricing Because we use our own products on a daily ba- We offer the full range or single packages of sis, we are constantly optimizing our products, membrane protein service from cloning to struc- services and application protocols.
34 Company Directory 2020 | health-made-in-germany.com Dr. Notghi Contract Research GmbH
Beuthstraße 7 Founded: 1999 10117 Berlin Employees: n.a. T +49 (30) 206 225-0 [email protected] F +49 (30) 206 225-100 www.notghi.com
Dr. Notghi Contract Research GmbH is an estab- with the contracts, projects and studies for the Target Discovery lished, independent German contract research or- development, safety and approval of pharma- Target Validation ganization headquartered in the heart of Berlin. ceuticals and medical devices. Hit Identification Lead Optimisation Since 20 years it has been on client’s behalf The Dr. Notghi Academy as a part of the CRO Preclinical Studies responsible for the development and safety of was founded ten years ago to train qualified Clinical Trials pharmaceuticals as well as approval of medici- experts for clinical research and pharmacovigi- nal products and devices. lance. The training programs are targeted to natural scientists, pharmacists and physicians, Dr. Notghi Contract Research GmbH is a quali- who are interested in clinical research. fied and flexible service provider for clinical trials, clinical evaluations as well as approval of We are your best partner in clinical studies and pharmaceuticals and medical devices. safety vigilance for pharmaceuticals and medical devices, as well as clinical evaluation of medical Our high standard of quality and good team devices. Dr. Notghi Contract Research GmbH spirit have always been rewarded by our clients stands for quality, experience and competence.
Dr. Regenold GmbH
Zöllinplatz 4 Founded: 1994 79410 Badenweiler Employees: n.a. T +49 (7632) 8226 0 [email protected] F +49 (7632) 8226 22 www.regenold.com
Regulatory requirements for the development, our network. Based upon your requirement we Target Discovery manufacturing, marketing authorization and assemble a project team with the specific ex- Target Validation subsequent monitoring of biologics must be pertise to deliver an optimal solution tailored to Hit Identification integrated within the complex biological and the challenges of each complex biologic product. Lead Optimisation medical context. Consequently, it is critical to Preclinical Studies link scientific and regulatory knowledge at a Clinical Trials very early stage in the development of biologics.
Our team includes biologists, biotechnologists, chemists, pharmacists, medical doctors and regulatory specialists. We have been supporting the development and regulatory affairs of new biological entities, biosimilars and Advanced Therapy Medicinal Products (ATMPs) for over ten years. If necessary our in-house team can be complemented by experienced experts within
35 company profiles
emovis GmbH
Wilmersdorfer Straße 79 Founded: 2001 10629 Berlin Employees: 50 T +49 (30) 3101-3610 [email protected] F +49 (30) 3101-3633 www.emovis.de
Target Discovery emovis has four different types of services to Home Care Visits in Clinical Trials Target Validation offer for Sponsors and CROs: Offering homecare visits in Clinical Trials all over Hit Identification Europe. (www.emovis-homecarevisits.de) Lead Optimisation Dedicated Research Site Preclinical Studies Located in Berlin. Outpatient studies phases Subsidary Camovis GmbH Clinical Trials II–III. High Recruiter. HIgh Data Quality. Founded Offering Site Support by Flying Study Nurses. in 2001. Experience in more than 120 indications. (www.camovis.de) Special Area of Interest: Psychiatric Indications. (www.emovis.de)
Patient Ward/Sleep Lab 3 beds dedicated to Clincial Research. Full Polysomnographic Equipment. Phase I studies in Patients, specifically in CNS indications. (www.emovis.de)
ENDOTHERM GmbH
Science-Park II Founded: 1999 66123 Saarbrücken Employees: n.a. T +49 (681) 3946 7570 [email protected] F +49 (681) 3946 7571 www.endotherm-lsm.com
Target Discovery Serving as a contract research organization Additionally, 3,500 “inhouse-made” research Target Validation (CRO), Endotherm Life Science Molecules is a chemicals can be selected from a continuously Hit Identification provider of medicinally relevant compounds updated catalogue. Finally, the company has Lead Optimisation for the development of novel small molecule established a technology platform for the syn- Preclinical Studies drugs and biomarkers for the development of thesis of complex chiral natural products, such Clinical Trials diagnostic devices. Particularly, the company as Vitamin D derivatives, in turn to be used for provides medicinal chemistry support for the assay design, as compound libraries for screen- discovery of new drugs to address unmet medi- ing, references, building blocks or for process cal needs. research purposes.
According to rational considerations and includ- ing computer assisted tools, focused compound libraries and single compounds for hit-finding, hit-to-lead studies and lead optimizations are designed and synthesized.
36 Company Directory 2020 | health-made-in-germany.com Evotec SE
Essener Bogen 7 Founded: 1993 22419 Hamburg Employees: 2,800 T +49 (40) 56081-0 [email protected] F +49 (40) 56081-222 www.evotec.com
Evotec is a drug discovery alliance and develop- unique position by assembling top-class scien- Target Discovery ment partnership company focused on rapidly tific experts and integrating state-of-the-art Target Validation progressing innovative product approaches with technologies as well as substantial experience Hit Identification leading pharmaceutical and biotechnology com- and expertise in key therapeutic areas including Lead Optimisation panies, academics, patient advocacy groups and neuronal diseases, diabetes and complications Preclinical Studies venture capitalists. of diabetes, pain and inflammation, oncology, Clinical Trials infectious diseases, respiratory diseases and We operate worldwide and our more than fibrosis. On this basis, Evotec has built a broad 2,800 employees provide the highest quality and deep pipeline of approx. 100 co-owned stand-alone and integrated drug discovery and product opportunities at clinical, pre-clinical and development solutions. discovery stages (EVT Innovate).
We cover all activities from target-to-clinic to Evotec has established multiple long-term alli- meet the industry’s need for innovation and ances with partners including Bayer, Boehringer efficiency in drug discovery and development Ingelheim, Celgene, CHDI, Novartis, Novo Nord- (EVT Execute). The Company has established a isk, Pfizer, Sanofi, Takeda, UCB and others.
eXcorLab GmbH
Industrie Center Obernburg Founded: 2005 63784 Obernburg Employees: 13 T +49 (6022) 81-2867 [email protected] F +49 (6022) 81-2676 www.excorlab.com
eXcorLab GmbH was founded in 1983 as a oxygenators, bone cements, wound dressings Target Discovery biomedical laboratory within Akzo Nobel. Since and (metal) implants in terms of e.g. perform- Target Validation 2005 the laboratory is an independent small and ance, hemocompatibility and cytotoxicity (e.g. Hit Identification medium enterprise (SME), specialized on R&D ISO 10993). Lead Optimisation contract research (CRO). The laboratory is ac- Preclinical Studies credited according to ISO 17025 which confirms eXcorLab GmbH accompanies the development Clinical Trials the competence in our area of work and the ap- of medical devices (e.g. dialysis and oxygena- plication of a strict quality management system. tion membranes, hemodialyzers, plasma separa- tors, oxygenators), and biomaterials (e.g. bone eXcorLab is performing ex vivo, animal and cements). We strive to provide relevant (in vitro) clinical studies of compounds, biomaterials or models for application of products in life sciences. medical devices in contact with freshly do- nated human blood, primary tissue (cells) or cell Our accreditation is recognized worldwide in lines. We assess membranes and equipment for more than 60 countries (including countries hemodialysis and blood oxygenation, dialyzers, within the EU, USA and Japan) based on the so hemofilters, adsorbers, blood lines, catheters, called ILAC arrangement.
37 company profiles
Experimentelle Pharmakologie & Onkologie Berlin-Buch GmbH
Robert-Rössle-Straße 10 Founded: 1997 13125 Berlin Employees: 45 T +49 (30) 9489 4440 [email protected] F +49 (30) 9489 4441 www.epo-berlin.com
Target Discovery EPO Berlin-Buch GmbH is one of Germanys for my new drug”, whereas the oncologist is Target Validation leading contract research organization (CRO) interested in: “which is the right drug for my pa- Hit Identification that has specialized in: tient”. EPO has developed large panels of tumor Lead Optimisation models providing efficient tools for preclinical Preclinical Studies Cancer Research Service drug development accelerating the initiation of Clinical Trials Providing tailored basic and translational clinical studies. research models to support drug development, starting from target validation and compound Personalized Medicine Service screening, and ending with integrational in vivo Experimental cancer models are used to support studies addressing pharmacology, pharmacoki- and personalize the selection of the most ap- netics, biomarkers, and tolerability. propriate drug treatment for the patient.
Translational Research Service Translational research in oncology from the per- spective of the drug developer should provide the simple answer: “who is the right patient
FGK Clinical Research GmbH
Heimeranstraße 35 Founded: 2002 80339 München Employees: 130 T +49 (89) 893 119 0 [email protected] F +49 (89) 893 119 20 www.fgk-cro.com
Target Discovery FGK Clinical Research GmbH is a Europe-based service to the sponsor. With our over 130 highly Target Validation full service Contract Research Organization with qualified medical, scientific and regulatory Hit Identification offices in Germany (HQ), Poland, Czech Republic experts, we have all the knowledge and experi- Lead Optimisation and Hungary. We provide full service for Phase ence necessary to succeed in Europe and can Preclinical Studies I–IV clinical studies. guide you through the clinical trial process, from Clinical Trials planning and approval to the final report. Our international client base includes biotech- nology, medical device, and pharmaceutical FGK Clinical Research has two daughter com- companies. Main areas of expertise are oncol- panies: FGK Pharmacovigilance and FGK Repre- ogy, CNS, dermatology and all major areas of sentative Service, enabling us to offer our clients internal medicine. pharmacovigilance services including services of QPPV and PMSF management as well as legal FGK has the right size to handle multi-country, representation for non- European customers multi-center studies with hundreds of patients conducting clinical studies or seeking marketing or single country studies with a few patients, authorisation within the EU/EEA. but is still small enough to guarantee a personal
38 Company Directory 2020 | health-made-in-germany.com Formula GmbH
Goerzallee 305 b Founded: 1995 14167 Berlin Employees: 10 T +49 (30) 7511054 [email protected] F +49 (30) 75702408 www.formula-pharma.de
Formula GmbH was founded as a highly innova- In recent years, the manufacturing license has Target Discovery tive company focussing on the development of been constantly expanded and adapted to the Target Validation medicinal products. Today, the development of needs of our customers. The manufacturing au- Hit Identification medicinal products is a core business segment of thorization and corresponding GMP certificate Lead Optimisation Formula GmbH with the objectives of formula- of Formula GmbH were successfully extended Preclinical Studies tion of solid, semi-solid, liquid and injectable by the primary and secondary packaging of Clinical Trials medicinal products. This also includes the de- market goods, their quality control and market velopment of lyophilizates, liposomes, infusible release. emulsions and sophisticated solid formulations, e.g. Multiple Unit Pellet Systems (MUPS). Galenical development is always successful if analytical development and validation of In 2005, Formula GmbH was granted a manufac- analytical methods as well as stability testing turing license for manufacturing clinical supplies are run in parallel. Therefore, our GMP-lab is regarding packaging, labelling, blinding, test- instrumentally equipped to provide the required ing and release of solid, semi-solid and liquid analytical services.” formulations for non-sterile products.
GALAB Technologies GmbH – GALAB Laboratories GmbH
Am Schleusengraben 7 Founded: 1992 21029 Hamburg Employees: 160 T +49 (40) 368077 400 [email protected] F +49 (40) 368077 401 www.galab.de
GALAB is a company with core competences in • Immobilized enzymes Target Discovery analysis and separation technology. • Affinity Chromatography Target Validation • Plant lectins Hit Identification GALAB offers analytical services, contract re- • Biotin conjugates Lead Optimisation search services and proprietary tools (AffiSep, • Assays Preclinical Studies AffiSpin, GlycoCleave) for the Health Care, Food • Customized products Clinical Trials and Biopharmaceutical Industry. After more than 20 years of experience in business and a Our special attention is addressed to product continuous improvement and extension of our quality and product safety that we achieve by competences GALAB has today acquired an continuous improvement and scientific research. outstanding market position. A sophisticated in-house quality assurance We offer products for the following fields of system, the monitoring of our products and appliciation: techniques, and an extensive documentation • Glycosciences guarantee a highest degree of reproducibility • Oligosaccharides and reliability.
39 company profiles
GBA Group Pharma – GBA Pharma Labs
Fraunhoferstraße 11a Founded: 1978 81252 Martinsried Employees: 160 T +49 (89) 899 229-0 [email protected] F +49 (89) 857 789-9 www.gba-pharma.com
Target Discovery GBA GROUP PHARMA – Your Experts for than 160 highly qualified employees and over Target Validation Pharmaceutical Analytics and Solutions. 4,500m2 of lab space. Hit Identification With a wide range of services, GBA GROUP Lead Optimisation PHARMA offers individual support throughout all Three more sites under the GBA GROUP PHAR- Preclinical Studies stages of pharmaceutical product life cycle – from MA roof are represented by ABF Pharmaceuti- Clinical Trials early lead optimization and early preclinical stage cal Services (Vienna, Austria) providing Clinical to global clinical studies, regulatory, marketing Trial Supply Management, LKF (Kiel, Germany) authorization, PPV and QP batch release testing offering Central Laboratory Services, as well as in addition to the logistics of commercials. Pharmacelsus (Saarbruecken, Germany) provid- ing Preclinical Drug Discovery and Development GBA GROUP PHARMA is a leading provider for Testing incl. In-Vitro GLP/non-GLP Bioanalysis. analytical and consulting services worldwide with six sites under one roof With a long-term expertise of over 30 years in the pharmaceutical business, GBA PHARMA The GBA PHARMA LABS run three GMP-certified LABS provide fast, flexible, and customer-ori- and FDA-inspected sites in Germany with more ented solutions.
GKM Gesellschaft für Therapieforschung mbH
Lessingstraße 14 Founded: 1981 80336 München Employees: 85 T +49 (89) 209120-0 [email protected] F +49 (89) 209120-30 www.gkm-therapieforschung.de
Target Discovery GKM is an independent, family-owned contract established long-term successful co-operations Target Validation research organization (CRO). We provide a com- with partner CROs world-wide. Hit Identification prehensive portfolio of services for the phar- Lead Optimisation maceutical industry, manufacturers of medical The GKM team is highly experienced and Preclinical Studies devices and academia. knowledgeable in scientific, organisational and Clinical Trials administrative matters of clinical research. With more than 38 years of expierence in the CRO business, GKM has completed over 900 As a mid-sized CRO, we are able to respond clinical research projects, including national and rapidly, efficiently and flexibly to your unique international clinical trials as well as non-inter- needs, corporate policies and processes at every ventional studies, involving approximately 1.5 stage of your project. million patients across various indications.
GKM cooperates with more than 90 freelance clinical research associates (CRAs) throughout Germany, Austria and Switzerland and has
40 Company Directory 2020 | health-made-in-germany.com glyXera GmbH
Brenneckestrasse 20 – ZENIT Founded: 2011 39120 Magdeburg Employees: 15 T +49 (391) 6117 -51 [email protected] F +49 (391) 6117-255 www.glyxera.com
glyXera is specialist provider of high-perform- We offer our clients sophisticated technology Target Discovery ance glycoanalysis, with products and services platforms and our expertise with respect to gly- Target Validation customizable to meet specific customer demands coanalytical products & services, tailored to the Hit Identification through using cutting edge methods and tools. specific needs of academia, clinics, pharmaceuti- Lead Optimisation cal and food industries. Preclinical Studies Our clients include the world’s leading pharma- Clinical Trials ceutical, biotechnology and food companies. We guide you for better decisions and help you to perform better and faster during discovery We provide fast and reliable glycoanalysis utiliz- phase, R&D, (clinical) trials and approval of your ing cutting edge systems with superior perform- innovative products (biopharmaceuticals, vac- ance and capacity, are the exclusive provider cines, food additives, functional food, etc.), and of glyXbox, a high-performance glycoanalysis QA/QC in your production stages. Standard op- system, and were awarded with the Innovation erating procedures (SOP) and a comprehensive Price of the bioregions Germany, therefore. quality management system ensure reproduc- ible analyses on highest levels and guarantees transparency through all processes.
Health Research Services GmbH
Hofäckerstraße 14 Founded: 2000 76698 Ubstadt-Weiher Employees: n.a. T +49 (7253) 9579-477 [email protected] F +49 (7253) 9579-480 www.h-r-s.biz
Health Research Services (HRS) Ltd, run offices personalized Health Medicine and therapeutic Target Discovery in UK, Germany, Moscow, Kiev and Warsaw. diet and food. Target Validation Hit Identification HRS GmbH is an independent contract research Consulting and Project Management in all stages Lead Optimisation organisation offering specialist services in the of drug development and Product Life Cycle. Preclinical Studies areas of Consulting, Scientific Drug Research Clinical Trials & Development, Project Management, Clinical Medical Writing Monitoring, Medical Writing, Biostatistics and The HRS medical writers are excellently trained Regulatory Affairs. medical or scientific experts.
HRS provides expert services to turn basic Biostatistical consultancy. research on promising new drug candidates into marketed medications. Regulatory Affairs – for Clinicals, Herbals and Dietary Supplements – in America, Asia, Aus- Service Provider for Pharmaceuticals and Nutri- tralia, Africa, Europe or UAE. tion Science so both the innovative area of
41 company profiles
Heidelberg Pharma AG
Schriesheimer Straße 101 Founded: 2004 68526 Ladenburg Employees: 70 T +49 (6203) 1009-0 [email protected] F +49 (6203) 1009-19 www.heidelberg-pharma.com
Target Discovery Heidelberg Pharma is a biopharmaceutical com- application to antibodies provided by custom- Target Validation pany and specialized in oncology and Antibody ers. It also provides its partners technological Hit Identification Targeted Amanitin Conjugates (ATACs) and also support in the manufacture and purification Lead Optimisation offers preclinical research services. The ATAC tech- of the conjugates, production and delivery of Preclinical Studies nology is a completely new treatment approach the compound, as well as necessary preclinical Clinical Trials for cancer therapy based on the unique biological research. mode of action of the toxin Amanitin and cou- pling it to tumor-specific antibodies. It works by In addition to collaborating with partners, inhibiting RNA polymerase II, which results in pro- Heidelberg Pharma is increasingly focused on grammed cell death (apoptosis). RNA polymerase developing its own therapeutic ATAC pipeline. inhibition is a novel principle in cancer therapy and offers the possibility of breaking drug resist- The company has the expertise and infrastruc- ance and destroying dormant tumor cells. ture for in vivo pharmacology and bioanalytics and offers preclinical research services outside As part of a hybrid business model, the Com- of ATAC technology for cancer, inflammatory pany grants licenses to its ATAC technology for and autoimmune diseases.
ICCR-Roßdorf GmbH
In den Leppsteinwiesen 19 Founded: 1999 64380 Roßdorf Employees: n.a. T +49 (6154) 8070 [email protected] F +49 (6154) 83399 www.iccr-rossdorf.de
Target Discovery The Institute for Competent Contract Research For customers from the medical device business Target Validation Rossdorf offers experimental toxicological ex- we offer modified protocols using extracts in ac- Hit Identification pertise since more than 3 decades. cordance to ISO 10993-1. Almost all toxicological Lead Optimisation studies are performed under GLP in accordance Preclinical Studies Our main business is the investigation of the to OECD Guidelines. Clinical Trials genotoxicological potency of pharmaceuticals, agrochemicals, cosmetics and chemicals. How- In addition, batch release testing of drugs under ever, several additional disciplines of toxicology, GMP has been performed since more than 10 mainly in vitro methods, are also in our portfolio years. (e.g. skin/eye irritation and corrosion, cytotoxic- ity, sensitisation testing).
42 Company Directory 2020 | health-made-in-germany.com Immundiagnostik AG
Stubenwald-Allee 8a Founded: 1986 64625 Bensheim Employees: 109 T +49 (6251) 70190-0 [email protected] F +49 (6251) 849430 www.immundiagnostik.com
Immundiagnostik AG develops and produces search institutions in the form of contract serv- Target Discovery innovative immunological tests (ELISA, EIA) ices, especially for the conduct of clinical trials. Target Validation and other analytical detection methods such Collaborations with the pharmaceutical industry Hit Identification as HPLC, LC-MS/MS and PCR) for routine and and memberships in scientific societies form the Lead Optimisation research in medicine. The aim is to provide high basis for a successful business development. Preclinical Studies quality, innovative and effective tools for the Clinical Trials prevention, differential diagnosis and treatment IDK owns more than 35 patents in Europe, the monitoring. Focus is on gastroenterology / nutri- US, Japan, Canada, and Australia,is certified ac- tion, cardiovascular / kidney, bone metabolism, cording to DIN EN ISO 13485 and fulfills the re- oxidative stress, complementary medicine / quirements of the German Medical Product Law preventive medicine, clinical immunology. (MPG) and the EU IVD Regulations (98/79 EG).
The product portfolio is complemented by a wide range of antigens and antibodies for research purposes. Business connections exist to clinical diagnostic laboratories and academic re-
INFAI GmbH
Gottfried-Hagen-Straße 60–62 Founded: 1988 51105 Köln Employees: 20 T +49 (221) 88044-3 [email protected] F +49 (221) 88044-55 www.infai.de
INFAI is at the leading edge in the transfer of of these tests is already licensed and available Target Discovery advanced analytical technology into medical for the routine diagnosis of Helicobacter pylori Target Validation diagnostics and the development of innova- infection. Other tests to determine gastric emp- Hit Identification tive pharmaceutical products. The company has tying rate and pancreatic insufficiency will soon Lead Optimisation pioneered the use of stable isotopes and NMR be available. Preclinical Studies in gastroenterology, metabolic diseases and Clinical Trials oncology. NMR spectroscopy and NMR imaging are used at INFAI to investigate a range of metabolic dis- INFAI’s laboratories in Cologne, Germany are orders and malignant conditions. The non-in- equipped with the most advanced NMR and vasive characteristics of these techniques make NMR imaging instrumentation. These facili- them particularly suitable for pediatric use. ties are used for in house research and product development and are also available for collabo- INFAI is affiliated with a range of companies rative and contract research.¶In the last years throughout Europe. we have developed a range of non-invasive and highly effective stable isotope breath tests. One
43 company profiles
Insilico Biotechnology AG
Meitnerstraße 9 Founded: 2001 70563 Stuttgart Employees: n.a. T +49 (711) 460594-19 [email protected] F +49 (711) 460594-10 www.insilico-biotechnology.com
Target Discovery Insilico Biotechnology AG develops and delivers maceutical companies worldwide use Insilico Target Validation predictive Digital Twins to advance biopharma- Digital Twins for cell line development, media Hit Identification ceutical process development and manufactur- design and process control on their journey to Lead Optimisation ing. Biopharma 4.0 and the factory of the future. Preclinical Studies Clinical Trials Insilico Digital Twins of cell culture processes Founded in 2001, Insilico Biotechnology is a lead to superior productivity, product quality, privately held company based in Stuttgart, and process robustness. Germany.
Groundbreaking predictive power is achieved by exploiting process data using artificial intelli- gence and biochemical networks.
As a result, Insilico’s unique approach substan- tially reduces experimental effort, costs of goods, and time to market. Leading biophar-
Institut für Atemwegsforschung (INSAF) GmbH
Biebricher Allee 34 Founded: 2003 65187 Wiesbaden Employees: 8 T +49 (611) 9854410 [email protected] F +49 (611) 9854348 www.insaf-wi.de
Target Discovery insaf is dedicated to research and development Insaf management is represented by renowned Target Validation of novel therapies and applications in respira- international experts and KOLs in the field of Hit Identification tory medicine, with particular focus on asthma, asthma and COPD management who frequently Lead Optimisation chronic obstructive pulmonary disease (COPD), engage in educational activities, lectures, advi- Preclinical Studies and allergic rhinitis. sory boards and trial monitoring committees. Clinical Trials We support clients from early stages of drug target identification through to design and per- formance of clinical studies phases I to IV.
In the past 15 years, we have conducted more than 100 clinical trials in respiratory indications in different severity stages.
44 Company Directory 2020 | health-made-in-germany.com IQVIA RDS GmbH
Unterschweinstiege 2–14 Founded: 1954 60549 Frankfurt Employees: 500 T +49 (69) 6604-0 [email protected] www.iqvia.com
IQVIA is a leading global provider of advanced tion of large-scale analytics, transformative Target Discovery analytics, technology solutions and contract technology and extensive domain expertise, Target Validation research services to the life sciences industry. as well as execution capabilities. With ap- Hit Identification proximately 61,000 employees, IQVIA conducts Lead Optimisation Formed through the merger of IMS Health and operations in more than 100 countries. Preclinical Studies Quintiles, IQVIA applies human data science – Clinical Trials leveraging the analytic rigor and clarity of data In Germany the IQVIA organization has about science to the ever-expanding scope of human 1.800 employees of which 500 are focused on science – to enable companies to reimagine and delivering best in class contract research services develop new approaches to clinical develop- including full functional service provisions. ment and commercialization, speed innovation and accelerate improvements in healthcare Together with our consulting, analytics and con- outcomes. tract sales and medical solutions teams we are providing also a full service to companies who Powered by the IQVIA CORE™, IQVIA delivers are planning to enter the Germany market. unique and actionable insights at the intersec-
JPT Peptide Technologies GmbH
Volmerstraße 5 Founded: 2004 12489 Berlin Employees: 100 T +49 (30) 6392-5500 [email protected] F +49 (30) 6392-5501 www.jpt.com
JPT Peptide Technologies is an ISO 9001:2015 • Proprietary technologies for peptide synthesis Target Discovery certified and GCLP compliant innovative service and high throughput screening Target Validation provider and research & development partner. • Integrated in-house R&D team for organic and Hit Identification medicinal chemistry, immunology and assay Lead Optimisation JPT’s proprietary peptide technologies help to ad- development, structural biology, bioinformat- Preclinical Studies vance projects for a variety of applications such as ics and data management Clinical Trials • Development of vaccines and immunotherapies • Solid track record of successful R&D projects • Immune monitoring and diagnostic content • Flexible business arrangements for collabora- research tive projects • Seromarker discovery and validation • ISO 9001:2015 and GCLP regulated quality as- • Vaccine target and epitope discovery peptide lead surance system discovery and systematic peptide optimization • Professional project management and com- • Discovery, clinical and functional proteomics munication JPT offers its services and contract research and JPT is the preferred partner for peptide related development project participation in flexible projects because of its: business arrangements.
45 company profiles
KOEHLER eClinical GmbH
Hornusstraße 16 Founded: 1987 79108 Freiburg Employees: 50 T +49 (761) 50318-0 [email protected] F +49 (761) 50318-30 www.koehler-eclinical.com
Target Discovery Since more than 25 years on the pharma market, We provide full service support for local and Target Validation KOEHLER eClinical GmbH is a mid-size specialty global trials with centralized project manage- Hit Identification CRO with more than 25 years experience in pro- ment and technology-enabled approaches for Lead Optimisation viding value-added services for our customers. early as well as late-phase projects, including Preclinical Studies With its strong heritage, KOEHLER eClinical is a NIS, observational and PASS. Clinical Trials major player in biostatistics, covering all aspects of the discipline including all study phases as well as biostatistical and regulatory consulting, meta- analyses, data integrations and -standardizations.
As specialist for data-centric approaches for decades now, the company operates its propri- etary software VITESSA as a combined tool for EDC and clinical trial management. Tailor-made and customized eClinical solutions are a part of our service promise.
LEUKOCARE AG
Am Klopferspitz 19 Founded: 2003 82152 Martinsried Employees: 42 T +49 (89) 780166-50 [email protected] F +49 (89) 780166-511 www.leukocare.com
Target Discovery LEUKOCARE AG, located in Martinsried, Ger- needs and can be used for dry and liquid for- Target Validation many, is a highly specialized biotech company in mulations. The rational development approach Hit Identification the field of formulation development. LEUKO- combines statistical software and algorithms. Lead Optimisation CARE’s expertise is based on two elements: the It consists of 5 steps: TPP alignment, analytics, Preclinical Studies proprietary Stabilizing and Protecting Solutions basic characterization, formulation development Clinical Trials (SPS®) formulation technology platform and the and a stability study. rational development approach. By combining these two elements, customized LEUKOCARE’s proprietary SPS® formulation and stable formulations will be tailored to the technology platform is based on a library of up customers‘ needs. LEUKOCARE’s unique ap- to 100 different, regulatory well-known excipi- proach can be applied to the following range of ents, e.g. selected amino acids. The excipients applications: biologics & biosimilars, virus & viral used are listed in pharmacopoeias (USP, EP, JP) vectors and biofunctionalized devices. and many of them are also listed as inactive ingredient by FDA. SPS® formulations are eas- ily adaptable to specific target molecules and
46 Company Directory 2020 | health-made-in-germany.com Life & Brain GmbH
Venusberg Campus 1 Geb. 76 Founded: 2002 53127 Bonn Employees: 40 T +49 (228) 6885-100 [email protected] F +49 (228) 6885-101 www.lifeandbrain.com
LIFE & BRAIN is a biomedical enterprise and LIFE & BRAIN Cellomics specializes in provid- Target Discovery commercial hub of the University of Bonn Medi- ing stem cell-based neuronal, neuroglial and Target Validation cal Centre. The combination of technological microglial cell types for disease modelling and Hit Identification know-how and scientific excellence makes LIFE target validation. As a leading partner of the Lead Optimisation & BRAIN the perfect partner for academic and stemcellfactory consortium L&B offers consult- Preclinical Studies commercial research. ing services in the field of automated stem cell- Clinical Trials based production processes. To date, LIFE & BRAIN GmbH has set up the fol- lowing business divisions: LIFE & BRAIN Neurocognition supports pre- LIFE & BRAIN Genomics is one of the leading Eu- clinical R&D programs in the area of neuro- ropean service providers for array-based omics degeneration, neurocognition and functional analyses. Our services encompass biobanking, connectomics by providing electrophysiological nucleic acid extraction, genotyping, epigenetic characterization of small molecules with focus analysis, expression analysis, third generation on target engagement, efficacy and potency in long read sequencing and bioinformatics. acute rodent and human brain slices, cultures, neurons and animal models.
Lionex GmbH
Salzdahlumer Straße 196 Founded: 1999 38126 Braunschweig Employees: n.a. T +49 (531) 2601-266 [email protected] F +49 (531) 2601-159 www.lionex.de
LIONEX is a German biotech company active rial diseases.¶LIONEX is the licensed, exclusive Target Discovery in the fields of biomedicine and human health manufacturer and distributor of a widely known Target Validation with special emphasis on TUBERCULOSIS (TB). family of endotoxin removal resin under the Hit Identification Our focus is on research and In-Vitro-Diagnostic brand name EndoTrap®. EndoGrade®Ovalbumin Lead Optimisation (IVD) product development for infectious dis- is another useful product for research on vaccine Preclinical Studies eases and cancer. LIONEX has recently launched development.Bovine tuberculosis tests are also Clinical Trials a new IGRA (Interferon Gamma Release Assay) available for research..LIONEX has state of the diagnostic test called LIOFeron®TB/LTBI for LTBI manufacturing facilities for IVD-Lateral Flow (Latent Tuberculosis Infection). It may also react Tests. All products are manufactured in Ger- positive in TB patients also but, as for other many. All productions are done under ISO13485 similar IGRA tests on the market, it cannot dif- certified conditions. ferentiate between LTBI and active TB. We are a highly reliable partner for OEM prod- LIONEX is a leading manufacturer of highly puri- ucts for companies active in manufacturing and fied, endotoxin free, mycobacterial antigens for distribution of such products. research on tuberculosis and other mycobacte-
47 company profiles
Lipotype GmbH
Tatzberg 47 Founded: 2012 01307 Dresden Employees: 16 T +49 (351) 796-5345 [email protected] F +49 (351) 796-5349 www.lipotype.com
Target Discovery Lipotype is a leading lipidomics provider and as well as for the small-scale profiling needs of Target Validation delivers comprehensive, absolutely quantitative academic researchers. Hit Identification lipid analysis services for clinical and biological Lead Optimisation samples on a high-throughput scale. Drawing on Lipotype is a spin-off company from the Kai Preclinical Studies many years of cutting-edge research experience, Simons and Andrej Shevchenko labs of the Clinical Trials Lipotype offers high quality targeted global world-renowned Max-Planck-Institute of lipidomics services for a wide range of custom- Molecular Cell Biology and Genetics in Dresden, ers and applications. Germany.
These services include biomarker identification LIPOTYPE – LIPIDOMICS FOR A BETTER LIFE and mode-of-action studies for clinical research- ers, GMP compliant quality control and assay development for pharma and biotech compa- nies, target validation and topical drug develop- ment for the cosmetics/dermatology industry,
Mediagnost GmbH
Aspenhaustraße 25 Founded: 1985 72770 Reutlingen Employees: n.a. T +49 (7121) 51484-0 [email protected] F +49 (7121) 51484-10 www.mediagnost.de
Target Discovery The Mediagnost Company, founded in 1985, is a Mediagnost is certified according to ISO Target Validation research based company dedicated to the devel- 13485:2016. All test systems for clinical diag- Hit Identification opment and manufacture of in-vitro diagnostic nostics are in compliance with the European Lead Optimisation test systems and cell culture derived biological Medical Device Directive 98/79/EC and are CE- Preclinical Studies reagents (viral antigens and antibodies). labeled. Clinical Trials Mediagnost has established state-of-the-art The entire company expertise in developing, labs, certified by the German authorities and validating and manufacturing clinical diagnostic in conformity with the laws relating to medical tests, as well as performing them, is available as devices, pathogens and genetic engineering. The service! laboratories in two security levels (L1/S1+L2/S2) are approved for handling human pathogens. The manufacturing processes, adhering to the GLP and GMP standards, are managed by sci- entists with qualified expertise in immunology, endocrinology, infectiology and virology.
48 Company Directory 2020 | health-made-in-germany.com Mediconomics GmbH
Misburger Straße 81B Founded: 1999 30625 Hannover Employees: 20 T +49 (511) 560998-0 [email protected] F +49 (511) 560998-20 www.mediconomics.com
Since 1999 Mediconomics GmbH has been a Mediconomics has earned an excellent reputa- Target Discovery premier provider for the Pharmaceutical and tion with leading enterprise pharmaceutical Target Validation Biotechnology industries. Our services include companies in the EU and the USA for the quality Hit Identification but are not limited to: Clinical Trial Services, of its work and for its combination of techno- Lead Optimisation Data Management, Pharmacovigilance, Product logical innovation and bottom-line orientation. Preclinical Studies Development, Regulatory Affairs and Medical Clinical Trials Writing for both medicinal products and medical Successful completion of tasks to client’s satis- devices. faction has brought more repeat business and increased new business. Mediconomics uniquely balances science and business to provide our clients competent and reliable safety and efficacy data on their prod- ucts and insights into the economic impact a new product might have on the client’s overall financial performance.
MEDICRO GmbH
Klostersteig 19 Founded: 2001 91580 Petersaurach Employees: 4 T +49 (9872) 9699-027 [email protected] F +49 (9872) 9699-029 www.medicro.de
MEDICRO is a full service CRO with experience medicinal products and medical devices are Target Discovery of more than 15 years. We offer services for growing continuously. Target Validation Interventional Studies Phase I–IV, Non-interven- Hit Identification tional Studies and Medical Device Studies. MEDICRO is fully committed to supporting you Lead Optimisation MEDICRO provide support for: Quality Assur- throughout the duration of your project, so that Preclinical Studies ance, Clinical Monitoring, Project Management, delays can be recognised early on and prevent- Clinical Trials Regulatory Affairs, Medical Writing, Clinical Trial ed. Our staff members’ motivation will make Management your trial a success. At MEDICRO, a nationally and internationally operating contract research organisation, we Special Services: Certified Translation Service focus our efforts on supporting your trial, your (English, Spanish, French, German). project, your wishes. We conduct clinical trials in the field of pharmaceuticals and medical MEDICRO organise Seminars AMG-Grund-, technology with utmost precision, in compliance Aufbau- und Aufrischungskurs. Also Seminars for with GCP, without red tape and with the high- Medical Devices (MPG – MDR). We have a course est quality standards. The costs for developing for study nurses and a CRA beginner course.
49 company profiles
menal GmbH
Im Hausgrün 15 Founded: 1992 79312 Emmendingen Employees: 20 T +49 (7641) 9333-46 [email protected] F +49 (7641) 9333-489 www.menal.de
Target Discovery menal GmbH is a GLP/GCP/GMP bionanalytical Since 2016 menal is able to provide high quality Target Validation laboratory based in Emmendingen/Germany. Since GMP analytics. Frequently in demand are potency Hit Identification 1992 menal supports the pharmaceutical industry assays like Anti IIa/Anti Xa HEPARIN and enzyme Lead Optimisation holistically in their research and development. activity assays. Preclinical Studies Pharmakokinetic and Pharmacodynamic/Biomar- Clinical Trials ker analytics are our strength. Customized projects and assays can be realized based on the high flexibility and more than 25 menal’s bioanalytical performances for R&D, years of experience. preclinical and clinical studies:¶Coagulation As- says, HPLC-UV, LC/MS/MS, ELISA, Enzym Activity Assays.
Merck Chemicals GmbH – Teil der Merck KGaA
Feldbergstraße 80 Founded: 1668 64293 Darmstadt Employees: 10,000 T +49 (6151) 3599-499 [email protected] F +49 (1805) 045-644 www.sigmaaldrich.com
Target Discovery Merck is a leading science and technology company the-art tools, services and expertise in order to Target Validation in healthcare, life science and performance materi- perform experiments and engineer new products. Hit Identification als. Around 50,000 employees work to further de- From drug discovery and development to manu- Lead Optimisation velop technologies that improve and enhance life. facturing and diagnostics, Merck are dedicated Preclinical Studies to solving the toughest problems in life science Clinical Trials Founded in 1668, Merck is the world’s oldest phar- by collaborating with the global scientific com- maceutical and chemical company. The founding munity. Our 300,000 products range from lab family remains the majority owner of the publicly water systems to gene editing tools, antibodies, listed corporate group. Merck holds the global cell lines and end-to-end systems to manufacture rights to the Merck name and brand. The only ex- drugs. We work closely with our customers from ceptions are the United States and Canada, where academia, biotech and pharma to help deliver the the company operates as EMD Serono, Millipore- promise of their work better, faster and safer. Sigma and EMD Performance Materials. To find out more about our products, please visit Before researchers can make scientific break- www.SigmaAldrich.com throughs, they must have access to state-of-
50 Company Directory 2020 | health-made-in-germany.com metabion GmbH – metabion international AG
Semmelweisstraße 3 Founded: 1997/2004 82152 Planegg Employees: n.a. T +49 (89) 899 363-0 [email protected] F +49 (89) 899 363-11 www.mymetabion.com
metabion is a globally leading supplier of and products are complementing metabion’s Target Discovery custom nucleic acids renowned for its focus on progressive and innovative approach within a Target Validation reliable supplies of consistently high quality healthy and sound business setup. Hit Identification products and services. Lead Optimisation metabion’s highly professional team of molecu- Preclinical Studies Starting its operations in late 1997, metabion has lar biologists, chemists, engineers and process Clinical Trials been providing the areas of academic research, technicians is dedicated to understand, antici- pharmaceutical & biotechnology development, pate, meet, and ideally exceed market require- and genetic diagnostics (human, animal, food, en- ments and quality standards by diligently listen- vironmental) with a wide range of synthetic DNA/ ing to our customers’ needs. RNA-based compounds for more than 20 years. Successfully translating highest quality stand- Daily applying and improving our core expertise ards into daily practice is the core of metabion’s in custom synthesis of nucleic acids and deri- business philosophy and key to its popularity at vates thereof, which are key components for any the same time. Careful evaluation and imple- molecular biological R&D activities, we strive to mentation of new and promising technologies contribute our share to Life Sciences’ progress.
Metronomia Clinical Research GmbH
Paul-Gerhardt-Allee 42 Founded: 1980 81245 München Employees: 65 T +49 (89) 829265-100 [email protected] F +49 (89) 829265-099 www.metronomia.net
Metronomia Clinical research: Our services: • Biostatistical consulting • Biosta- Target Discovery Data. People. Excellence. tistical services and statistical programming • Target Validation Metronomia is an expert CRO for biostatistical Clinical data management • Medical Writing • Hit Identification consulting, biostatistical services and clinical Randomization/IWRS Lead Optimisation data management, located in Munich, Germany. Preclinical Studies Experience: • More than 500 projects • All clini- Clinical Trials We offer high-quality clinical research services cal phases and NIS • All major therapeutic areas • to pharmaceutical and biotech companies, along Small molecules, biologicals, biosimilars, medical with the medical device industry. devices, orphan drugs and pediatric clinical trials
Since the foundation in 1990, Metronomia was Our commitment: • Exceptional flexibility • successfully involved in more than 500 clini- Personal service through stable project teams • cal projects, covering every clinical stage and Productive, long-lasting, trustful relationships project size throughout all major therapeutic • High-quality and reliability of our data • Effi- areas. cient processes and state-of-the-art technology
51 company profiles
micro-biolytics GmbH
Schelztorstraße 54–56 Founded: 2001 73728 Esslingen a.N. Employees: 24 T +49 (711) 400 52-410 [email protected] F +49 (711) 400 52-800 www.micro-biolytics.com
Target Discovery MICRO-BIOLYTICS is a leading service and solu- Since 2001, micro-biolytics has been developing Target Validation tion provider for analytical chemistry with in- and producing analytical instruments for digitiz- Hit Identification dustry expertise across Pharmaceutical, Chemi- ing liquids that can do more – and are better. Lead Optimisation cal, Life Science and Food industry. Preclinical Studies We are constantly inventing, testing and Clinical Trials The company delivers comprehensive services optimizing. that support its customers digitalization road- map towards efficient, secure and reliable value chains.
Our AquaSpec™ MIRA Analyzer revolutionizes the supply chain of the chemical, biotechnical and pharmaceutical industries through digital enablement of chemical analysis through cloud, artificial intelligence and big data technologies.
Microcoat Biotechnologie GmbH
Am Neuland 3 Founded: 1992 82347 Bernried Employees: 150 T +49 (8158) 9981-0 [email protected] F +49 (8158) 9981-10 www.microcoat.de
Target Discovery Microcoat’s Laboratory Services comprise a • PK and immunogenicity assays for pre-clinical Target Validation comprehensive selection of both off the shelf and clinical environments in compliance with Hit Identification and individualized solutions, supporting large all relevant guidelines. Lead Optimisation molecule drug development from the very early • Biomarker selection support, assay validation Preclinical Studies discovery phase through GLP preclinical re- and sample analysis based on a broad techno- Clinical Trials search, GCP clinical studies and up to postmar- logical spectrum ranging from high-throughput keting surveillance. automation to ultra-sensitive multiplexing In close cooperation with our customers, we aim platforms. for best performance, based on an extensive • Fully validated bioanalytical LIMS for manage- portfolio of advanced technologies paired with ment of studies and samples, guaranteeing trace- uncompromised quality standards. ability and data integrity at highest standards. Based on more than 25 years of professional • Dedicated teams with a high degree of aca- experience, we assist our clients in the develop- demic members supervise our projects from ment and tailor-made validation of bioanalyti- conception to result. cal assays for their specific targets and applica- Contact us to discuss your individual request tions. with our bioanalytical experts.
52 Company Directory 2020 | health-made-in-germany.com MicroDiscovery GmbH
Marienburger Straße 1 Founded: 2000 10405 Berlin Employees: n.a. T +49 (30) 44350-900 [email protected] F +49 (30) 44350-9010 www.microdiscovery.de
MicroDiscovery develops and produces software MicroDiscovery has a strong track record in Target Discovery and hardware solutions for mHealth, in-vitro- creating analysis systems for molecular data, Target Validation diagnostics and biomedical research enabling image analysis, classification and medical device Hit Identification personalized medicine. control. This includes the design and realization Lead Optimisation of dedicated algorithms in the fields of Genom- Preclinical Studies Our innovative analysis system, mo:Test, a ics, Proteomics and Metabolomics. Clinical Trials smartphone based user friendly reader for lateral flow test evaluation makes diagnostics Solutions can be developed and documented mobile. Quick high quality readout, quantifica- as required for CE certification and FDA compli- tion and reliable documentation are guaranteed ance. Complementary bioinformatics and bi- in all applications. Intelligent integration of a ostatistics services support your study planning, smartphone makes the system fully autono- biomarker validation, data processing, data inte- mous and reduces maintenance effort. mo:Test gration and data management. MicroDiscovery is easily adaptable to single or complex multi- is DIN ISO 9001:2015 certified by TÜV Rheinland. parameter assays.
MicroMol GmbH
Am Hubengut 3 Founded: 1996 76149 Karlsruhe Employees: 20 T +49 (721) 9415213 [email protected] F +49 (721) 9415214 www.micromol.com
MicroMol GmbH Company biological contamination, especially: • Protein Target Discovery MicroMol has focussed its portfolio on 3 defined characterisation by amino acid composition Target Validation topics within the field of Biological Risk Assess- (ninhydrin positive substances according to Hit Identification ment. Ph.Eur. 2.2.56) • Protein characterisation by size Lead Optimisation The section of Biological Safety concentrates and immunological reactivity • Determination Preclinical Studies on the analysis of Medical Devices (ISO 10993), of biological contamination (DNAse, RNAse, Clinical Trials Pharmaceuticals and Biologics in general. In this residual DNA/RNA/Protein, HCP, Mycoplasma) context MicroMol offers an independent and ac- credited platform for: • Pyrogen testing by MAT • Last but not least the platform is complemented Cytotoxicity in vitro • Skin testing in vitro Irrita- with a section for Microbiology concentration tion/Sensitisation/Corrosion • Determination of He- on the analysis of: • Cell bank purity/Bacteri- mocompatibility • Determination of Genotoxicity ophage detection and characterisation • Biobur- den, LAL, and Genotoxicity testing The section of Bioanalytics focusses on several aspects within the field of Protein-/Immune- Micromol is GMP certified and ISO 17025 ac- and Cell analytics as well as the assessment of credited.
53 company profiles
Micromun – Privates Institut für Mikrobiologische Forschung GmbH
Walther-Rathenau-Straße 49a Founded: 1993 17489 Greifswald Employees: 19 T +49 (3834) 515-600 [email protected] F +49 (3834) 515-605 www.micromun.de
Target Discovery MICROMUN Privates Institut für Mikrobiol- MICROMUN gives expert opinion on disinfect- Target Validation ogische Forschung GmbH is a specialised private ants with respect to their action against viruses. Hit Identification laboratory which offers complete services on MICROMUN sells a spectrum of diagnostic an- Lead Optimisation the field of virology. tigens from own production for the creation of Preclinical Studies MICROMUN develops test methods and investi- immunologicals assays. Clinical Trials gates drugs according to GMP for pharmaceuti- MICROMUN investigates substances with cal manufacturers. respect to antiviral and cyto toxic potency and MICROMUN applies cell biological-, molecular developes corresponding assays on customer biological-, immuno chemical- and biochemical request. methods for this purpose. MICROMUN carries out virus- and TSE clearance MICROMUN provides methods to determine the studies according to the rules of GLP to proof infective virus burden in drugs which are de- the safety of pharmaceutical manufacturing rived from biological sources. Drug preparations processes. are quantitatively inspected for the presence of MICROMUN’s animal laboratory is specialised on bacterial endotoxins with the aid of the LAL as- toxicological investigations in connection with say according to the european pharmacopoeia. TSE and is certified according to GLP.
Minerva Analytix GmbH
Ladestraße 6 Founded: 2013 15834 Rangsdorf Employees: 9 T +49 (33708) 5282-0 [email protected] F +49 (33708) 5282-99 www.minerva-analytix.com
Target Discovery Minerva Analytix develops, validates and per- Since your time is precious our focus are rapid Target Validation forms assays for routine or custom detection of microbiological methods i.e. nucleic acid amplifi- Hit Identification microbial contaminations. cation (NAT) methods. Lead Optimisation Preclinical Studies Our service portfolio includes mycoplasma, Our methods are state-of-the-art using the lat- Clinical Trials bacteria and virus diagnostic and contamination est technology available in biopharmaceutical control. industry.
We perform analysis on various biotechnological Team up with us to profit from more than 18 materials, such as cell cultures or biopharma- years of experience gained by own research and ceutical products e.g. ATMPs, media or supple- intensive partnering. ments.
54 Company Directory 2020 | health-made-in-germany.com MLM Medical Labs GmbH
Dohrweg 63 Founded: 1993 41066 Mönchengladbach Employees: 80 T +49 (2161) 4642-102 [email protected] F +49 (2161) 4642-190 www.mlm-labs.com
MLM Medical Labs is a GLP-certified, CLIA-, offers central lab services in over 40 countries, Target Discovery CAP- and ISO15189 accredited central laboratory especially in Europe, USA and China. Target Validation dedicated exclusively to clinical trials. Hit Identification The extensive lab portfolio is complemented Lead Optimisation MLM offers full laboratory services, including a by a superior IT infrastructure (e.g. mlm online®, Preclinical Studies whole range of analytics: standard safety pro- MLM Sample Storage System®) and the MLM Kit Clinical Trials files, such as blood counts, coagulation, urinaly- Building® services for customized sampling kits. sis, clinical chemistry, and analyses of biomark- ers, drug compounds, metabolites and molecular diagnostic parameters.
The MLM lab is on duty 365 days a year to en- sure valid results with a quick turnaround time. With their strategic partners Cenetron Central Laboratories in Austin, USA and Teddy Clinical Research Laboratory in Shanghai, China MLM
OakLabs GmbH
Neuendorfstr. 16b Founded: 2011 16761 Hennigsdorf Employees: 12 T +49 (3302) 2265-479 [email protected] F +49 (3302) 209-2705 www.oak-labs.com
OakLabs GmbH is a privately held AI company OakLabs’ team of life scientists and quantum Target Discovery founded in 2011 near Berlin, Germany. It collabo- physicists has extensive real-world experience Target Validation rates with pharma and diagnostic companies turning drug development projects into success Hit Identification worldwide to develop predictive biomarkers of stories. Lead Optimisation superior accuracy and thus to boost the success Preclinical Studies of drugs in the clinical trials or on the market. Clinical Trials
OakLabs can look back at more than 8 success- ful years on the market with a proven track record and an ISO 9001 certification which was acquired in 2018. In the same year, a new office in Boston, USA, opened.
55 company profiles
OmicScouts GmbH
Lise-Meitner-Straße 30 Founded: 2014 85354 Freising Employees: n.a. T +49 (8161) 976289-0 [email protected] F +49 (8161) 976289-1 www.omicscouts.com
Target Discovery OmicScouts is a chemical proteomics company OmicScouts supports your drug and biomarker Target Validation focused on supporting drug and biomarker dis- discovery projects with end-to-end solutions Hit Identification covery with its unique expertise and innovative tailored to project specific needs. Lead Optimisation technologies. Preclinical Studies Clinical Trials Founded by leading proteomics researchers, the company has a track record in delivering signifi- cant collaborations with top pharmaceutical and biotechnology companies.
We provide and develop proteome-wide assays that work with native proteins in a physiological setting and enable the identification of small molecule drug targets, target engagement mark- ers, molecular mechanisms of action and drug response biomarkers.
OmniComm Europe GmbH
Kaiserstraße 139–141 Founded: 2007 53113 Bonn Employees: 20 T +49 (228) 227440 [email protected] www.omnicomm.com
Target Discovery History and mission • 6,000+ studies worldwide, involving more than Target Validation Founded in 1997, OmniComm Systems, Inc. has 65,000 investigator sites in more than 60 coun- Hit Identification developed into a leading global provider of clinical tries. 45,000+ eTrained users. Lead Optimisation data management technology. With approximately • Experience in 30+ therapeutic areas, Phase Preclinical Studies 180 employees, OmniComm has offices around I–IV, Medical Device, Academic, NIH/Govern- Clinical Trials the globe. The company’s commitment to innova- ment, Nutraceutical. tion is evident in its introduction of major product • User support around the clock with full-service enhancements every year for the last 17 years. Lev- customer support in 18 languages. 100% staffed eraging an extensive global experience from more with OmniComm employees in four locations than 6,000 clinical trials, OmniComm provides worldwide (USA, Germany, Japan, India). comprehensive eClinical solutions for research. • Interoperability with external systems to quickly and easily exchange data. Our cur- Highlights rent technology supports CDISC, SDTM, ODM, • Data centers in in the U.S., Europe and China. CDASH, HL7 and E2B.” • EU-U.S. Privacy Shield Framework and Swiss- U.S. Privacy Shield Framework Certification.
56 Company Directory 2020 | health-made-in-germany.com PEPperPRINT GmbH
Rischerstraße 12 Founded: 2001 69123 Heidelberg Employees: 25 T +49 (6221) 726-4488 [email protected] F +49 (6221) 726-4475 www.pepperprint.com
PEPperPRINT is the leading provider of high printing technology. PEPperCHIP® Peptide Target Discovery density peptide microarrays for linear and Microarray can be analysed by the customer Target Validation conformational epitope mapping, antibody or by PEPperPRINT experts. The PEPperMAP® Hit Identification validation, antigen and epitope discovery and Service portfolio comprises all microarray-based Lead Optimisation serum bio- experiments, data analysis and a comprehensive Preclinical Studies marker development in cancer, autoimmune and report. Clinical Trials infectious diseases for the development of IVD and CDx tests. We are looking for academic and industrial researchers interested in new biomarkers for The company, located in Heidelberg, provides detection or monitoring of autoimmune and in- the PEPperCHIP® Peptide Microarray platform fectious diseases, pharma companies for patient with an unrivalled content flexibility, signal stratification in immuno-oncology and diag- quality and peptide diversity. Besides a number nostic companies for licensing our rheumatoid of standard peptide arrays, user defined custom arthritis, psoriatic arthritis and Zika virus epitope peptide microarrays can be prepared in short biomarkers. turnaround times based on a proprietary laser
peptides&elephants GmbH
Neuendorfstraße 20b Founded: 2001 16761 Hennigsdorf Employees: 12 T +49 (3302) 202-2000 [email protected] F +49 (3302) 202-2001 www.peptides.de
peptides&elephants, based on its innovative Through product innovation, responsive service Target Discovery and integrated technologies, is providing the full and ongoing support we help our customer to Target Validation range of peptides for all research areas. take their studies to success. Hit Identification Lead Optimisation Our catalogue of immunological peptides has peptides&elephants, your research is our priority! Preclinical Studies grown over 18 years of innovative and high- Clinical Trials quality peptide synthesis expertise. We are able to provide you with high-quality peptides for various applications as neurosciences, cell signaling and cell penetrating, cardiovascular, diabetes, cancer and apoptosis, host defense, epigenetics, peptides hormones.
57 company profiles
PharmaInformatic
Friesenstraße 36 Founded: 2004 26721 Emden Employees: n.a. T +49 (4921) 993360 [email protected] F +49 (4921) 993361 www.pharmainformatic.com
Target Discovery PharmaInformatic provides cheminformatic The expert system IMPACT-F forecasts drug- Target Validation services and predictive tools to optimize drug uptake of a compound in humans. It is used by Hit Identification discovery. Since 2004 we develop comprehen- pharmaceutical companies in different thera- Lead Optimisation sive ADME/Tox databases. They contain phar- peutic areas such as diabetes, inflammation, Preclinical Studies macokinetic results from human clinical trials antivirals, autoimmune diseases and cancer for Clinical Trials and preclinical animal trials. selection and prioritization of drug candidates, to optimize leads and to evaluate oral bioavail- Reliable tools to predict ADME/Tox-properties ability before clinical trials in humans. of compounds such as oral bioavailability, clear- ance, elimination half life, volume of distribu- This ranking allows the most efficient drug-can- tion, plasma protein binding or toxicity can be didates to be chosen for further development.” derived from our databases in order to identify and prioritize promising drug candidates.
PHARMALOG Institut für klinische Forschung GmbH
Oskar-Messter-Straße 29 Founded: 1983 85737 Ismaning Employees: 30 T +49 (89) 544637-0 [email protected] F +49 (89) 544637-50 www.pharmalog.com
Target Discovery PHARMALOG your professional partner for clini- We have experience in the performance of mul- Target Validation cal studies. Our team of academics undertakes tinational and national studies with a network Hit Identification phase I and phase II–IV studies for you. of centres throughout Europe. Lead Optimisation Preclinical Studies We work for the pharmaceutical and biotechnol- We offer excellent value for your money having Clinical Trials ogy industries and for producers of food supple- short channels of communication and direct ments, cosmetics and medical devices. assignment of responsibility for efficient opera- tions. We are also happy to implement post-marketing and pharmacoeconomic studies for you. We undertake both complete research projects and special tailored services depending on your specific requirements.
58 Company Directory 2020 | health-made-in-germany.com PortaCellTec biosciences GmbH
Philipp-Reis-Str. 2A Founded: 2009 37075 Göttingen Employees: n.a. T +49 (551) 30966440 [email protected] F +49 (551) 30966442 www.portacelltec.de
PortaCellTec (PCT) provides a broad spectrum • Customized experimental design Target Discovery of assays with hepatic/renal uptake transport- • Detailed study plan Target Validation ers (e.g. OATs, OCTs, OATPs) as well as efflux • Professional performance of transporter assays Hit Identification transporters (e.g. MDR1, BCRP and BESP) to in- Lead Optimisation vestigate the inhibitory potential and substrate Inhibition studies Preclinical Studies characteristics of drugs. As recommended by • Two point inhibition Clinical Trials FDA and EMA PCT perform in vitro studies with • Determination of IC50 value validated drug transporters stably-transfected • Determination of the inhibition character by in HEK-293 cells. Dixon Plot analysis
As experts on drug transporter studies, we pro- Substrate studies vide the following services: • Transport kinetics: time- and concentration • Consulting service for transporter selection dependent uptake • Advice regarding FDA and EMA guidelines for • Determination of affinity (Km and Vmax) SLC- and ABC-Transporter proteins • Study report adapted to customers’ needs.
preclinics Gesellschaft für präklinische Forschung mbH
Wetzlarer Straße 20 Founded: 2006 14482 Potsdam Employees: 15 T +49 (331) 243433-50 [email protected] F +49 (331) 243433-51 www.preclinics.com
preclinics is a CRO that offers preclinical studies Besides in vitro culture assays, xenograft models Target Discovery for the development of drugs, drug delivery are available for in vivo testing of e.g. biologics Target Validation formulations and medical devices. or biosimilars on human targets. preclinics also Hit Identification offers the custom immunization of various spe- Lead Optimisation We are experienced in cardiovascular, inflamma- cies – from mice to horses. Preclinical Studies tory, orthopedic, hematological and oncological Clinical Trials indications. Especially the development of new Most interesting is the immunization of llamas models for efficacy testing of novel compounds and alpacas for generating heavy-chain anti- and therapeutical concepts is a focus of our bodies and VHHs. services. From all species we also provide high quality One major product is the Revolyzer, a revolution fresh blood or tissue products. analyzer for voluntary running assays (VRA). VRA are a versatile and promising method that became very sensitive and convenient with the Revolyzer.
59 company profiles
Premier Research
Europaplatz 5 Founded: 1989 64293 Darmstadt Employees: 56 T +49 (6151) 520-1600 [email protected] F +49 (6151) 520-1602 www.premier-research.com
Target Discovery Premier Research, a clinical research company, is specific therapeutic areas, Premier Research is Target Validation dedicated to helping biotech, specialty pharma, committed to helping its customers answer the Hit Identification and device innovators transform life-changing unmet needs of patients across a broad range of Lead Optimisation ideas and breakthrough science into new medi- medical conditions. Preclinical Studies cal treatments. Clinical Trials Visit premier-research.com. As a global company, Premier Research special- izes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors.
Whether it’s developing product lifecycle strate- gies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in
PRIMACYT Cell Culture Technology GmbH
Hagenower Straße 73 Founded: 2004 19061 Schwerin Employees: n.a. T +49 (385) 3993-600 [email protected] F +49 (385) 3993-602 www.primacyt.com and www.primacyt.services
Target Discovery PRIMACYT is a leading provider of in vitro tech- Drug Administration (FDA), and the European Target Validation nologies and services for product development Medicines Agency (EMA). Hit Identification in human and animal health and for bioaccu- Lead Optimisation mulation and clearance studies in the area of Primacyt has established and validated an assay Preclinical Studies environmental toxicology. platform utilising stable transfected HEK-293 Clinical Trials cell lines and primary human and animal hepa- PRIMACYT has a laboratory certified according tocytes to assay drug transporter activities. to Good Laboratory Practice (GLP) since 2006 and serves as a reference laboratory for the In addition, we offer studies to analyse hepa- European Union since 2013. totoxicity, metabolism, and Cytochrome P450 activities in 2D and 3D hepatocyte cultures. The knowledge of drug affinity and drug-drug interaction (DDI) to uptake and efflux transport- ers is a fundamental requirement in drug devel- opment, recommended by the Pharmaceuticals Medical Devices Agency (PMDA), the Food and
60 Company Directory 2020 | health-made-in-germany.com proDERM GmbH
Kiebitzweg 2 Founded: 1994 22869 Schenefeld Employees: 100 T +49 (40) 839 358-0 [email protected] F +49 (40) 839 358-39 www.proDERM.de
proDERM is an internationally renowned CRO proDERM has established an excellent reputa- Target Discovery with a specialized focus on studies relating tion as a high-quality provider of trial services, Target Validation to skin and mucous membranes. The institute on the basis of an outstanding technical set-up Hit Identification offers customized and innovative solutions to and expertise, including Confocal Microscopy, Lead Optimisation Sponsors worldwide. The services include phase Raman Spectroscopy and many state-of-the art Preclinical Studies I studies in a dedicated clinic as well as multi- skin measuring devices. Clinical Trials center studies in their growing network of quali- fied sites in Germany.
Profil Germany GmbH
Hellersbergstraße 9 Founded: 1999 41460 Neuss Employees: 450 T +49 (2131) 4018-345 [email protected] www.profil.com
As a full service CRO, Profil carries out early By owning a database of more than 25.000 Target Discovery phase clinical trials for research on obesity, (pre) well characterized individuals (healthy, healthy Target Validation diabetes, and diabetes complications. Profil was at-risk, type 1 and type 2 diabetes) Profil can re- Hit Identification founded in 1999 as a spin-off of an academic cruit even the most complex studies in this area. Lead Optimisation study group at the department of metabolic Preclinical Studies diseases and nutrition at University of Düssel- Profil has a fully GMP certified pharmacy and Clinical Trials dorf. two in-house clinics with 80+ beds and holds expertise in Data Management & Statistics and One of the core technologies is the hyperin- Regulatory Affairs. sulinemic euglycemic clamp, used to address action profiles of insulin and insulin analogues, beta cell function and insulin sensitivity.
Profil has been involved in the development of all major antidiabetic compounds and enjoys an excellent scientific reputation worldwide.
61 company profiles
ProJect Pharmaceutics GmbH
Fraunhoferstraße 22 Founded: 2010 82152 Martinsried Employees: 10 T +49 (89) 452289-700 [email protected] F +49 (89) 452289-717 www.project-pharmaceutics.com
Target Discovery Development. Formulation. Process. Packaging. organic solvent systems up to liposomal encap- Target Validation ProJect Pharmaceutics is one of the leading Eu- sulation • Lyophilisation in vial, dual chamber Hit Identification ropean CROs specialised in accelerated, state-of- system, syringe, bulk tray, containers in nest&tub Lead Optimisation the-art formulation and drug product develop- configuration • In-depth analytical evaluation • Preclinical Studies ment for (bio-)pharmaceuticals, biologics, ADCs, Selection of suitable container closure system Clinical Trials small molecules and cytotoxics (up to OEL4), as • Evaluation of process robustness and design also viral and non-viral nanoparticular products space • Smooth technology transfer and scale-up (up to BSL-2). • Aseptic manufacturing of preclinical supplies.
Services and solutions We support our worldwide clients to develop a • Biopharmaceutics • Formulation profiling, pre- consistently high-quality pharmaceutical prod- formulation, early state and late phase formula- uct, scalable and manufacturable under GMP tion, liquid and lyophilized • Highly concentrated conditions. Being teamed up with manufacturing protein formulation • UF/DF concentration stud- experts (CMO) allows one-stop-shop solutions. ies • Downstream process optimisation • Forced stress and stability studies • Freeze-drying from www.project-pharmaceutics.com
Prolytic GmbH
Weismüllerstraße 45 Founded: 2003 60314 Frankfurt am Main Employees: 16 T +49 (69) 3487 234-10 [email protected] F +49 (69) 3487 234-99 www.prolytic.de
Target Discovery Prolytic is a German GLP/GCP laboratory for We are your partner for: Target Validation bioanalysis and pharmacokinetic evaluation. • Preclinical studies Hit Identification We provide our clients with the development • Dose-finding studies Lead Optimisation and validation of analytical methods, analyse • Toxicological studies Preclinical Studies samples from pre-clinical, clinical and toxstud- • Pharmacokinetic studies Clinical Trials ies, and also conduct compartmental and non- • Toxicokinetic studies compartmental pharmacokinetic evaluation. • Clinical trials (Phases 0–III) • Bioequivalence/bioavailability studies Our expertise are: • Bioanalysis for small and large molecules (LC/ MS-MS and ELISA) • Pharmacokinetic evaluation with WinNonLin¶• RNA/DNA Analysis • Highest Quality through GLP/GCP certification • Over 25 years experience in drug development
62 Company Directory 2020 | health-made-in-germany.com Proteome Factory AG Proteome Factory AG
Magnusstraße 11 Founded: 2000 12489 Berlin Employees: n.a. T +49 (30) 206162-65 [email protected] F +49 (30) 206162-67 www.proteome-factory.com
Proteome Factory AG is a Berlin based biotech For technical enzymes or monoclonal antibodies Target Discovery company specialized in protein analysis with where hybridoma cells are lost we perform de Target Validation mass spectrometry, chromatography, electro- novo sequence elucidation. Hit Identification phoresis (1D/2D) and Edman sequencing. Lead Optimisation Consult our specialists for a tailored proposal Preclinical Studies We perform for example sequence valida- that matches your requirements. Clinical Trials tion, profiling of oxidized and acidic variants, determination of glycoforms, confirmation of disulfide pattern and intact masses of biophar- maceuticals APIs like mAB, fusion proteins and others.
PXBioVisioN GmbH
Feodor-Lynen-Straße 5 Founded: 2008 30625 Hannover Employees: 2 T +49 (511) 538896-4 [email protected] F +49 (511) 536696-6 www.pxbiovision.com
PXBioVisioN GmbH supports research-based The “Differential Peptide Display” analysis Target Discovery pharmaceutical companies in meeting the many approach: Methodically, the hypothesis-free Target Validation challenges that arise in the discovery, research analysis approach is based on the mass spectro- Hit Identification and development of new active substances and metric analysis of all extracted native peptides Lead Optimisation modern drugs. and low-molecular weight proteins of biological Preclinical Studies samples (plasma, tissue, urine, cell culture sam- Clinical Trials The methods and techniques summarized ples, etc.) intended for differential comparison. under “Peptidomics Technologies” have been researched by us for 20 years, continuously The procedures, processes and protocols are uni- developed and individually adapted according versally and versatilely applicable – as accom- to customer requirements. panying analytics in clinical study phases and for the clarification of complex pharmacological PXBioVisioN GmbH accompanies explorative and clinical effect profiles, for the identification clinical studies and early phases of pharmaceu- of biomarkers and potential active substances tical research as a service provider and reliable or lead structures for synthetic molecules, for partner on behalf of its customers. the stratification of volunteers and patients, etc.
63 company profiles
SanaClis DE GmbH
Olof-Palme-Straße 15 Founded: 2000 60439 Frankfurt Employees: 3 T +49 (69) 5870035-0 [email protected] F +49 (69) 5870035-29 www.sanaclis.eu
Target Discovery SanaClis was founded in 2000 by seasoned In addition to being a full-service CRO, SanaClis Target Validation industry experts all of whom have had execu- is one of the very few service providers who has Hit Identification tive level positions in leading pharma companies in-house logistics capabilities. This includes QP Lead Optimisation and large global CROs. SanaClis is a full-service services, customs brokerage, warehousing and Preclinical Studies European CRO offering a comprehensive range distribution, and sourcing of clinical trial materi- Clinical Trials of services for clinical trials. als, comparators and rescue medication.
SanaClis has experience of successfully deliver- ing studies for various sized sponsors, starting from virtual biotechs through to top 10 pharma companies. Every project is a priority for the SanaClis team, irrespective size or scope. We believe that every company and professional deserves to feel that they are getting the best possible service, responsiveness, and dedication that we routinely provide to our existing clients.
SequentiX – Digital DNA Processing
Dorfstraße 20 Founded: 2005 18249 Klein Raden Employees: 1 T +49 (38462) 22-333 [email protected] F +49 (38462) 33-9807 www.sequentix.de
Target Discovery Sequentix – Digital DNA Processing offers We also offer professional digital DNA analyses Target Validation bioinformatic services and software for the software for sequence assembly, alignment, Hit Identification analysis of DNA, RNA and protein data.¶¶Our cluster analyses and cladistics, and DNA frag- Lead Optimisation main expertise is the assembly, proof reading ment/fingerprint analyses (AFLP, RFLP, t-RFLP, Preclinical Studies and alignment of DNA sequence data, as well RAPD, PFGE). Clinical Trials as phylogenetic cluster analysis and molecular fingerprint analysis. Our services help medical and biotechnology companies as well as research institutions save For identification of organisms, determination on expensive expertise costs and thereby mini- of pathogens and documentation of genetic re- mize their own costs. latedness we analyse and process our customers raw data sets, combine them with public avail- able sequence data, and deliver publication- ready results and graphics.
64 Company Directory 2020 | health-made-in-germany.com Seramun Diagnostica GmbH
Spreenhagener Straße 1 Founded: 1992 15754 Heidesee Employees: 70 T +49 (33767) 791-10 [email protected] F +49 (33767) 791-99 www.seramun.com
Seramun Diagnostica GmbH was founded in application in ELISA, Blot and Microarrays and Target Discovery Brandenburg (near the capital Berlin) more stabilizers for enzyme conjugates, proteins and Target Validation than 20 years ago and has established itself proteohormones. Our reagents and services Hit Identification as a competent manufacturer and eveloper of are used worldwide by IVD manufacturers and Lead Optimisation reagents for immunoassays like ELISA, blot and scientific institutions. An internationally distrib- Preclinical Studies microarrays and for in-vitro diagnostic kits in uted product range of more than 90 CE marked Clinical Trials the field of autoimmune and infectious diseases. IVDs for the diagnosis of infectious and autoim- mune diseases is also based on the company’s Seramun’s services include production, purifica- own reagents and developments. tion and labeling of monoclonal and polyclonal antibodies, production and purification of recom- The new automatable technology platform binant proteins and cultivation and preparation SeraSpot® offers microarrays on the basis of of bacterial pathogens at the company’s premises. microtitration plates with up to 25 different parameters in one well for the application in The product range of reagents comprises human and veterinary diagnostics. chromogenic substrates for HRP and AP for the
Sirius Fine Chemicals SiChem GmbH
Fahrenheitstraße 1 Founded: 2001 28359 Bremen Employees: 12 T +49 (421) 2208-228 [email protected] F +49 (421) 2208-226 www.sichem.de
SiChem synthesizes fine chemicals and diag- candidates are successfully tested against sev- Target Discovery nostic tools for biochemical, biomedical, and eral pathological conditions, for instance cystic Target Validation pharmaceutical research (photoactivatable and fibrosis (CF), diarrhea, and inflammation. Hit Identification fluorescent). Recently we supplemented our Lead Optimisation portfolio by clickable unnatural amino acids SiChem has developed efficient preparative Preclinical Studies and (pegylated) tools for Click-Chemistry. The techniques in the area of enantioseparation and Clinical Trials strained rings which are used in copper-free purification (up to the 1,000kg scale). We also Click-Chemistry (i.e. transcyclooctene) are also support you in the area of classical custom syn- triggering the release of APIs: The click reaction thesis. If more specialist tasks are involved, such and thus the selected cleavage of tumor-bound as metabolite synthesis of current APIs (D /13C) antibody drug conjugates (ADCs) can be a pow- we are also the people to turn to. erful tool in ADC therapy. We provide: multi-step organic synthesis from SiChem’s unique expertise is based on the syn- targets and chiral building blocks – Separation thesis of compounds with biologically increased of racemic mixtures – Purifying compounds bioavailability (prodrugs). The masked drug
65 company profiles
SSS International Clinical Research GmbH
Landsberger Straße 23/25 Founded: 1993 82110 Germering Employees: 50 T +49 (89) 800650-0 [email protected] F +49 (89) 800650-555 www.cro-sss.com
Target Discovery SSS International Clinical Research GmbH was certification (DIN EN ISO 9001) was performed Target Validation founded as a Clinical Research Organisation by Intertek. Hit Identification (CRO) in September 1993 in Munich, Germany. Lead Optimisation Since 2013 SSS International Clinical Research Preclinical Studies Since then the company has acquired ample ex- GmbH is member of the German association of Clinical Trials perience in setting-up and running clinical trials contract research organizations (BVMA) after in many European countries. passing a qualification audit.
Over the last 20 years SSS has established inter- Services national co-operations in Western, Central and • Full service phase II–IV, NIS, IIT Eastern Europe. New offices of SSS were opened • International project management to cover the Eastern European market with own • Site selection, patient recruitment strategies staff in 2007 (Romania) and 2008 (Poland). • Clinical monitoring • GCP training (in-house, on-site, on-line) The quality system of SSS was certified accord- ing to DIN EN ISO in 1997. In June last 2012 re-
StarSEQ GmbH
Johann-Joachim-Becher-Weg 30a Founded: 2008 55128 Mainz Employees: 6 T +49 (6131) 3925397 [email protected] www.starseq.com
Target Discovery StarSEQ aims to offer a complete service in the It is our strong belief that our service can add Target Validation analysis of genetic material. Our main priorities value to your budget. Hit Identification are our orientation towards our customers and Lead Optimisation our careful advisory service. We promise to you high-quality standards, Preclinical Studies ensured by our highly motivated scientific team Clinical Trials Starting in 2008 as a company with an ex- which has more than 30 years experience in traordinary affordable DNA sequencing service DNA sequencing and genome analysis. we have expanded our service covering next generation sequencing, bioinformatics, genotyp- ing, extensive industrial services and personal genomics.
We have important clients throughout 40 countries worldwide, among them giants of the chemical and pharmaceutical industries.
66 Company Directory 2020 | health-made-in-germany.com SynapCon Ltd.
Wenzel-Jaksch-Straße 2a Founded: 2006 65199 Wiesbaden Employees: 20 T +49 (611) 703-97054 [email protected] F +49 (611) 710-29495 www.synapcon.com
SynapCon Ltd. offers effective innovations and clinical trial projects better and faster then ever Target Discovery sustainable IT solutions for better performance before or your competitors. Target Validation of your clinical research projects. Our solutions Hit Identification are customized for small and medium enterprises EasyClin© is a revolutionary Clinical Trial Man- Lead Optimisation to benefit from almost 30 Years of clinical re- agement System (CTMS) control and manage Preclinical Studies search and 20 Years of IT architecture experience. the clinical development of pharmaceutics and Clinical Trials EasyClin(c) feasibility, EasyClin(c) TMF, EasyClin(c) any kind of medical products. ISF and the management modules guarantees remarkable cost and time savings. Our systems Our deep knowledge about the entire value chain are 21 CFR Part 11 compliant and the compliance makes EasyClin© the perfect CTM system, to infrastructure will be delivers. In case you are raise standards and improve the quality of docu- hosting our systems on your own servers we are mentation in clinical trials, save time & money glad guiding you thru the validation process. along the entire value chain of clinical research.
Due to our experience we can support you using Please ask for a free online demonstration to the software in the best way performing your learn more about our unique business concept.
SYNLAB Analytics & Services Germany GmbH
Bayerstraße 53, 6. Stock Founded: 1994 80335 München Employees: 300 T +49 (89) 741393-0 [email protected] F +49 (89) 741393-39 www.synlab.de
SYNLAB Pharma, a segment of the Business Unit SYNLAB Pharma supports the complete drug Target Discovery SYNLAB Analytics & Services Germany GmbH development cycle from preclinical toxicology and Target Validation of the SYNLAB Group, offers a very broad range PK projects through all clinical phases and beyond. Hit Identification of laboratory services to the biotechnology and Lead Optimisation pharmaceutical industries as well as to manu- Our clients take advantage of our large spectrum Preclinical Studies facturers of medical devices and novel foods. of analytical methods for drug development and Clinical Trials production control; always working in accordance SYNLAB Pharma’s portfolio includes global with the highest standards such as DIN/EN ISO/ clinical trial services, bioanalytical services, ad- IEC 17025/15189, GMP, GLP, GCLP or GCP. vanced biomarker testing, personalized medi- cine concepts, logistics, long-term sample stor- See us as your ONE-STOP-SHOP – and take ad- age, production monitoring incl. extractables & vantage of our experience gained in more than leachables, product release and stability studies. 25 years and 3,500 clinical trials.
67 company profiles
Taros Chemicals GmbH & Co. KG
Emil-Figge-Straße 76a Founded: 1999 44227 Dortmund Employees: 60 T +49 (231) 9742-7211 [email protected] F +49 (231) 9742-7219 www.tarosdiscovery.com
Target Discovery Taros, a privately owned chemistry CRO has Holistic drug discovery chemistry Target Validation been serving pharmaceutical, biotech and Taros core expertise in Drug Discovery encom- Hit Identification chemical companies since 1999. Within our drug passes: Lead Optimisation discovery division, our mission is to accelerate • Medicinal chemistry from hit validation Preclinical Studies potential new medicines into clinical develop- to candidate selection • Expertise on many Clinical Trials ment. Taros adds considerable value to drug biomolecular targets across all main therapeutic discovery collaborations by boosting collabora- areas • Dedicated group for computational tors’ discovery programs from target validation chemistry and molecular modeling • Partners for and hit identification to lead generation and outsourcing disease biology, HTS, ADME, DMPK, optimization. Taros’ capabilities include me- X-ray crystallography • Strong track record dicinal chemistry, computational sciences and in compound library design and production innovative compound libraries. Taros has been by parallel syntheses • Excellence in custom leading the chemistry activities of the European synthesis, process development and scale-up to Lead Factory (ELF) and is also in the lead of its pilot plant manufacturing” recent continuation ESCulab. Moreover Taros is involved in the Drug Discovery Hub Dortmund.
TherapySelect Dr. Frank Kischkel
Carl-Bosch-Straße 4 Founded: 2011 69115 Heidelberg Employees: 6 T +49 (6221) 8936-157 [email protected] F +49 (6221) 8936-158 www.therapyselect.de
Target Discovery The intention of TherapySelect is to help indi- Besides using the CTR-Test for cancer patients, Target Validation vidual cancer patients to find an effective anti- the test can also be applied to increase the Hit Identification cancer therapy (personalized medicine). Thera- success of clinical trials. Unsuccessful clinical Lead Optimisation pySelect’s goal is to increase patient’s survival trials are the most expensive obstacle in drug Preclinical Studies and quality of life as well as to reduce costs in development. The success of clinical trials can Clinical Trials healthcare system. significantly be increased by using a diagnos- tic test to identify patients susceptible to the TherapySelect offers the CTR-Test (Cancer specific drug. When a drug is applied to pa- Therapy Response-Test), which can measure the tients, who are resistant to the tested drug, no efficacy of cancer drugs on living tumor cells to or wrong conclusions could be drawn regarding identify the best therapy option for an individ- the general efficacy of this drug. The CTR-Test ual cancer patient before start of a therapy. This can help to find appropriate patients for clinical test is able to identify inefficient drugs before trials. start of chemotherapy with a very high prob- ability (>95 %). In general the CTR-Test can be used for all drugs directly acting on tumor cells.
68 Company Directory 2020 | health-made-in-germany.com TRIGA-S Scientific Solutions
Mühltal 5 Founded: 1998 82392 Habach Employees: 80 T +49 (8847) 69578-0 [email protected] F +49 (8847) 69578-29 www.triga-s.de
TRIGA-S Scientific Solutions is an owner-man- and life-science associations. All our services are Target Discovery aged contract research organization. For more based on GxP guidelines and the quality certifi- Target Validation than 20 years we are successfully conducting cation DIN EN ISO 9001:2015. Hit Identification clinical and technical studies for in-vitro diag- Lead Optimisation nostic products and medical devices. During that Based on our years of experience, our high Preclinical Studies time, we successfully completed more than 100 quality standard and our excellent team of Clinical Trials different studies at more than 500 study sites international scientists, TRIGA-S is a reliable and worldwide with more than 1 million samples. competent partner for tailor-made solutions in the field of clinical and technical studies. Our study services comprise management, monitoring and logistics. Additionally, we oper- ate a S2 laboratory for contract measurements and controlled storage facilities for human sam- ple material. Furthermore, we provide biosta- tistics support and cooperate with an excellent network of manufacturers, partner companies
vertis Biotechnologie AG
Lise-Meitner-Straße 30 Founded: 2000 85354 Freising Employees: 5 T +49 (8161) 18516-11 [email protected] F +49 (8161) 18516-12 www.vertis-biotech.com
VERTIS is a research-oriented company in the tagRNA-seq, dual RNA-seq, Cappable-seq, etc., Target Discovery field of functional genomics. The strength of our to our customers. Our consequent use of a Target Validation service is customer-oriented flexibility which is robotic system for NGS library preparation guar- Hit Identification based on our innovative technology platform antees highly reproducible data, more consistent Lead Optimisation which we have developed in our 20-year history. yields and higher quality data. Preclinical Studies Clinical Trials Services We offer a complete product line, ranging from We offer innovative tools and strategies for the project consulting, nucleic acid isolation, NGS comprehensive qualitative and quantitative library preparation, DNA sequencing to bioinfor- analysis of bacterial and eukaryotic transcrip- matic sequence analysis and data mining. tomes, using state-of-the-art Next Generation Sequencing (NGS) of RNA molecules (RNA-seq).
Special emphasis of VERTIS lies in the analy- sis of bacterial transcriptomes. We are able to provide specialised applications like dRNA-seq,
69 company profiles
Vibalogics GmbH
Zeppelinstraße 2 Founded: 2001 27472 Cuxhaven Employees: 50 T +49 (4721) 565-400 [email protected] www.vibalogics.com
Target Discovery Live virus manufacturing, including aseptic fill quality clinical trial material including compre- Target Validation and finish, is Vibalogics’ expertise. We work hensive GMP documentation to facilitate our Hit Identification with virotherapies, including oncolytic viruses customers’ product development strategies on Lead Optimisation and gene vectors and are a partner for compa- time and within budget. Preclinical Studies nies committed to developing innovative drugs Clinical Trials for life-threatening diseases. Our one-stop-shop services include process development, assay development, cGMP-compliant manufacturing, filling, lyophilization, formulation development, and QC testing.
We offer a highly competent team of experts and a biosafety level 2 state-of-the-art facility. Four independent GMP production suites with cleanroom class areas A-D provide a high level of manufacturing flexibility. We deliver high-
VivaCell Biotechnology GmbH
Ferdinand-Porsche-Straße 5 Founded: 1999 79211 Denzlingen Employees: 5 T +49 (7666) 9028-77 [email protected] F +49 (7666) 9028-78 www.vivacell.de
Target Discovery Vivacell is a service provider with a strong focus • Inhibition 5alpha-reductase (hair growth, pros- Target Validation on pharmacological testing (drug efficacy). Our tatic hyperplasia) Hit Identification main activities are in the field of phytopharma- • Vanilloid (=Capsaicinreceptor) and menthol Lead Optimisation ceuticals, drugs, nutraceuticals cosmetics and receptor (pain, warming, cooling, hair growth) Preclinical Studies oral care. • Histamine-release (allergy), histamine induced Clinical Trials inflammation Examples of some recent activities: • Lipolyse in human primary adipocytes • Immunmodulation/anti-inflammatory/wound • cosmetics screening healing/sinusitis/bronchitis (metabolic activity, proliferation, cytokines, leukotrienes, humane Apart of these drug efficacy studies we offer monocytes, chondrocytes, keratinozytes) preclinical studies (e.g. Ames Test). • Receptor binding studies, neurotransmitter- reuptake (anxiety, depression, memory effects, dyspepsia) • Viral entry model, inhibition viral neuramini- dase (common cold)
70 Company Directory 2020 | health-made-in-germany.com Winicker Norimed GmbH
Deutschherrnstraße 15–19 Founded: 1993 90429 Nürnberg Employees: 134 T +49 (911) 92680-0 [email protected] F +49 (911) 92680-8839 www.winicker-norimed.com
Winicker Norimed GmbH, established in 1993, Thanks to our many years of experience in the Target Discovery is a full service Contract Research Organiza- management and conduct of clinical investiga- Target Validation tion. We offer a full range of services in clinical tions with medical devices as well as nutritional Hit Identification research from planning through reporting. products with health promoting properties, Lead Optimisation we are able to provide you with effective and Preclinical Studies In cooperation with hospitals and primary care individual solutions. Clinical Trials physicians, we manage phase II–IV clinical trials as well as non-interventional and epidemiologi- Another main focus of our work is Market Ac- cal studies with pharmaceuticals and studies cess and Health Service Research. with medical devices.
Zentrum für Humangenetik und Laboratoriumsdiagnostik
Lochhamer Straße 29 Founded: 1998 82152 Martinsried Employees: 120 T +49 (89) 895578-0 [email protected] F +49 (89) 895578-780 www.medical-genetics.de
The diagnostic expertise covers the analysis of methylation profiles. Other important methods Target Discovery body fluids and tissue samples with molecu- include flow cytometry (FACS scan) and tandem Target Validation lar genetic, cytogenetic, flow cytomteric and mass spectrometry. Hit Identification biochemical techniques. Our molecular diagnos- Lead Optimisation tics portfolio comprises the whole spectrum of The highly qualified medical, scientific and tech- Preclinical Studies advanced technologies such as multi-gene panel nical staff offers comprehensive and individual Clinical Trials sequencing (MGPS), clinical exome sequencing support services for physicians regarding all (CES), whole Exome sequencing (WES) and RNA clinical and diagnostic questions. sequencing. The interdisciplinary collaboration between Other applications of next generation sequenc- five medical specialist areas (Human genetics, ing (NGS) include HLA typing, NIPT(Prenatalis® Laboratory Medicine, Microbiology/Virology, and Veracity®) and Microbiome Analysis (Entera- Transfusion Medicine, Molecular Oncology/ lis™). We also employ several array platforms Pathology) enables diagnostic questions to be such as AffymetrixTM, AgilentTM or Illumina iScanTM more efficiently, comprehensively and accu- to perform array CGH, SNP array analyses and rately resolved.
71 OUR PARTNERS Industry Associations HEALTH MADE IN GERMANY works closely together with the German Industry Assocations to provide support to international companies seeking to establish partnerships or to settle in Germany. Together we provide you with all of the industry information you need. Association of German Biotech Companies Biotechnologie-Industrie-Organisation (VBU) in DECHEMA e.V. Deutschland (BIO Deutschland) From its beginning, the VBU (Vereinigung Deut- The Biotechnologie-Industrie-Organisation scher Biotechnologieunternehmen) set out to en- Deutschland (BIO Deutschland) is an independ- able technology transfer and facilitate network- ent organization for innovative biotechnology ing between academic research and industry. companies in Germany. At its offices in Berlin, With a special focus on small and medium sized the association is developing and supporting an enterprises, the VBU offers advice and organizes innovative industry based on modern life sci- events tailored to give information and support ences. Founded in October 2004, BIO Deutschland to start-ups during their growth and expansion currently has more than 320 member companies phase, both nationally and internationally. Being and several supporting members and sector a part of DECHEMA, the large network for chemi- partners. To support its members BIO Deutschland cal process technology and biotechnology, it is engages in a broad range of activities, including the home for people active in research whether lobbying, public relations, and offering business in universities, independent research institutions, development opportunities. Using a wide range start-ups or “big businesses”. The activities of of political initiatives, BIO Deutschland lobbies for VBU supplement the approximately 120 topical improvements to legal parameters for innovative working groups within DECHEMA, around 20 of small and medium-sized enterprises. The associa- them covering biotechnology from Omics and Cell tion is also very active in a broad range of events Culture to Bioprocessing and Single-Use Tech- with the aim of providing biotechnology with a nologies. platform for discussion and interaction.
www.v-b-u.org | www.dechema.de www.biodeutschland.org
German Association of Biotechnology Federal Association of Contract Research Industries (DIB) Organisations (BVMA e.V.) The German Association of Biotechnology Indus- Founded in July 1991, the »Bundesverband tries (DIB) and its national, European and global Medizinischer Auftragsinstitute« (BVMA) represents networks are the voice and leading industry CROs (Contract Research Organisations) in German representation for the innovative and dynamic speaking countries. The association promotes Good biotechnology industry that operates in and from Clinical Practice (GCP) and requires from its mem- Germany. DIB is the biotechnology division of bers a strong commitment to the quality stand- the Association of the German Chemical Industry ards adopted at the General Assembly. The BVMA Association (VCI). DIB’s members constitute all maintains close relations with the pharmaceutical in all about 95 % of the biotechnology business industry, media, physicians/investigators, regula- operating in and from Germany. DIB’s mission is to tory authorities and ethic committees, in order to advocate national, EU and international policies contribute to the continuous development of scien- and legislation that uphold a natural science and tific methodology as well as regulatory and ethical risk-based approach, foster innovation, operate in matters in clinical research. BVMA hosts an annual a predictable and proportionate way, enable the symposium that provides an excellent platform for industry to perform efficiently, protect intellec- interdisciplinary exchange between all stakehold- tual property and reward the introduction of new ers. An informal Get-together the evening before technologies and practices. presents a well perceived networking opportunity.
www.dib.org www.bvma.de
73 our services
HEALTH MADE IN GERMANY
Germany is one of the world’s most important networking platforms including trade events providers and exporters of healthcare products at home and abroad. The initiative serves four and services. The country’s innovative medical major industries active in the international products set international standards for quality, medical market: pharmaceuticals, medical safety and reliability. German manufacturers and technology, medical biotechnology, and digital service providers in all health and life sciences health care. segments attract overseas customers and partners and deliver leadership in healthcare innovation. HEALTH MADE IN GERMANY also works closely HEALTH MADE IN GERMANY is the export with 16 major German industry associations and initiative for the German healthcare industry. is part of the BMWi’s MITTELSTAND GLOBAL It supports international companies and umbrella program for small and medium-sized organizations that are interested in establishing enterprises. The initiative is ideally placed to contact with potential German partners and provide access to German healthcare market suppliers. Set up by the German Federal Ministry information and to help overseas businesses for Economic Affairs and Energy (BMWi), the identify potential German partners. initiative bundles expert market intelligence for easy industry access. One of the initiative’s main The HEALTH MADE IN GERMANY initiative is goals is to promote the German healthcare sector implemented by Germany Trade & Invest, the through international networking activities for economic development agency of the Federal the mutual benefit of international partners and Republic of Germany, on behalf of the BMWi. German companies alike.
HEALTH MADE IN GERMANY does this by providing proactive support (including market For more information: and regulatory insight), introductory services, and www.health-made-in-germany.com
Our support for your business:
We publish market briefs, in-depth We take part in leading healthcare market studies and company directories trade fairs all over the world, organize of the German healthcare industry and its networking events and enjoy ongoing different sectors. dialogue and exchange with international health policymakers. Our calendar is regularly updated with the latest industry events in Germany Visit www.health-made-in-germany.com and overseas. for more information about the German healthcare industry and all HEALTH MADE We provide free access to 3.500+ German IN GERMANY activities. healthcare companies with our online data- base. Detailed company profiles and direct contact information help international businesses to identify potential suppliers and partners in Germany.
74 Contract Research Organizations | health-made-in-germany.com contact
Expert Advice Imprint
Publisher Germany Trade and Invest Gesellschaft für Außenwirtschaft und Standortmarketing mbH Friedrichstraße 60 10117 Berlin Germany
Executive Board Dr. Jürgen Friedrich, Chairman/CEO Dr. Robert Hermann, CEO
Editor Axel Lohse, Germany Trade & Invest, Berlin
Axel Lohse is the manager responsible for the Author medical biotechnology and pharmaceutical BIOCOM AG, Berlin industries at HEALTH MADE IN GERMANY. He is your point of contact for expert advice in those Layout fields and looks forward to receiving your inquir- BIOCOM AG, Berlin ies and requests. Print Get in touch with us to learn more about what Kern GmbH, 66450 Bexbach HEALTH MADE IN GERMANY can do for you. www.kerndruck.de
Axel Lohse Notes Manager, Medical Biotechnology and All rights reserved. Pharmaceuticals © Germany Trade & Invest, January 2020 Reproduction, in whole or in part, only permissible T +49 30 200 099-254 with express prior authorization. All market data [email protected] provided is based on the most current market www.health-made-in-germany.com information available at the time of publication. www.gtai.com Germany Trade & Invest accepts no liability for the actuality, accuracy, or completeness of the information provided.
Order Number 21169
Picture Credits Title: Elnur/stock.adobe.com; page 2: Sergey/stock. adobe.com; page 4: Robert Przybysz/stock.adobe. com; page 6: nd3000/stock.adobe.com; page 7: Hoda Bogdan/stock.adobe.com; page 8: sergeyklopotov/ stock.adobe.com; page 9: pressmaster/stock. adobe.com; page 10: Sved Oliver/stock.adobe.com; page 15: MyMicrostock/Stocksy/stock.adobe.com; page 72: Anna Om/stock.adobe.com; page 75: Illing & Vossbeck Fotografie
75 About us Germany Trade & Invest (GTAI) is the economic development agency of the Federal Republic of Germany. The company helps create and secure extra employment opportunities, strengthening Germany as a business location. With more than 50 offices in Germany and abroad and its network of partners throughout the world, GTAI supports German companies setting up in foreign markets, promotes Germany as a business location and assists foreign companies setting up in Germany. All investment services and related publications are free of charge.
Germany Trade & Invest Germany Trade & Invest Headquarters Bonn Office Friedrichstraße 60 Villemombler Straße 76 10117 Berlin 53123 Bonn Germany Germany T +49 (0)30 200 099-0 T +49 (0)228 249 93-0 F +49 (0)30 200 099-111 F +49 (0)228 249 93-212 [email protected] [email protected] www.gtai.com www.gtai.de