In Silico and In Vitro Testing Resources

Alcyomics, Ltd., offers in vitro human-based pre-clinical drug safety testing. It manufactures SkimuneTM (human skin explants for safety and efficacy testing) and offers immunogenicity services, efficacy testing of immunomodulators, hypersensitivity testing, potency assessment, cellular and cytokine assays and safety assessment services.

AllCells, LLC, offers more than 150 primary cell types and related RNA and cDNA from normal and disease-state tissues.Cell types include stem cells (progenitor, CD34+, etc.), hematopoietic, human hematologic disease, endothelial, dendritic, HUVEC cells and many others. It also offers services such as drug discovery, device validation, flow cytometry and cell sorting, tissue culture protein analysis and genotyping as well as stem cell and immune assays.

Alternative Toxicity Services offers high-content screening for evidence-based acute general toxicity and neurotoxicity.

APSciences, Inc., offers Integrated Discrete Multiple Organ Co-culture (IdMOC) technology, which is an in vitro model consisting of multiple, inner wells within a larger interconnecting chamber. It is based on the concept that the multiple organs in a human (or other animal) are physically separated but interconnected by the systemic circulation (i.e., blood). IdMOC can be used to evaluate drug toxicity, drug metabolism and drug distribution as well as anti-cancer drugs for cytotoxicity, efficacy and mechanism of action.

Asterand, PLC, provides high quality, well characterised human tissue through its worldwide network of 75 active collaborative donor institutions and human tissue-based research solutions to drug discovery scientists. It also provides a collaborative scientific approach to deliver human tissue-based data ontarget and biomarker validationas well ascompound potency, effect and safety.

Attagene, Inc., offers unique screening services for the evaluation of biological activities and prediction of potential toxicities of pharmaceuticals, agricultural and industrial chemicals, cosmetics and nanomaterials.Using its proprietary pathway profiling platform, the FACTORIAL™, Attagene has developed a suit of bioassays that assess the impact of a compound on activities of over 90 gene regulatory pathways and all 48 human nuclear receptors.

AvantiCell Science, Ltd., offers medium- to high-throughput cell-based screening on a range of cell types with relevance to human disease, nutrition and well being. Services include cell-based screening, natural products and traditional medicines service, lead development assays, customised assay development and contract research and development.

AxioMx specialises in recombinant antibody discovery and development. Recombinant antibodies can be used in the same applications as traditional antibodies but have numerous advantages such as being human-based (allowing for the use in therapeutic applications) and allowing for the generation of unstable, toxic, immunosuppressant, or non-immunogenic antigens. AxioMx’s synthetic recombinant antibody libraries contain more than ten billion unique clones.

BIOalternatives is a contract facility that specialises in cellular and molecular pharmacology and provides in vitro testing services to the pharmaceutical, cosmetics and nutrition industries. Biopta, Ltd., provides customised testing services for the pharmaceutical industry using fresh, functional human tissues. Human tissues are obtained from surgeries, biopsies and transplants and may be sourced from healthy patients or those with diseases such as psoriasis, inflammatory bowel disease or chronic obstructive pulmonary disease.

BioScience Laboratories, Inc., is a testing laboratory that conducts investigative studies for both standard and customised in vitro and clinical studies. It offers testing for topical antimicrobial products, disinfectants, wound care, medical devices, cosmetics and personal care products.

BioSeek is a drug discovery services company that applies human primary cell assays and predictive disease models to the discovery and development of human therapeutics and safer chemicals. Its BioMAP®platform uses human primary cells and co-cultures to deliver physiologically relevant insights about a test compound.

Bioskin is a contract research organisation specialising in dermatology studies. It conducts clinical trials for pharmaceuticals, medical devices, food supplements and cosmetics.

BioTeSys GmbH provides chemical analysis, clinical trials and in vitro analysis for sectors such as the food industry, cosmetics and consumer healthcare.

Biotox, SRL, provides scientific and project management services related to toxicology, chemicals safety assessment and alternative methods to animal testing. Areas of consultancy include toxicology risk assessment and in vitro methods, REACH support and European Union representation and lobbying.

Celentyx, Ltd., offers the Immuno-Profiling™ platform for rapid analysis of drug action on physiological and pathological human immune tissues and cells. It also offers NCIP™, which allows for rapid analysis of drug action on human immune tissues and cells to predict potential therapeutic utility in a number of conditions (e.g., inflammation, autoimmune disease, allergy, prevention of graft rejection, lymphoma and leukaemia).

Cellasys GmbH offers system solutions for real-time analysis of living cells, including various lab-on-a- chip technologies to monitor parameters such as cellular viability, pH, temperature and oxygen. Testing services include drug testing, environmental monitoring, food testing, chemical risk assessment and research on diabetes, nutrition and biofuels.

CellSystems Biotechnologie Vertrieb GmbH develops and produces primary cell culture systems, stem cell culture systems, three-dimensional cell culture models and three-dimensional human skin models (epiCS) for regulatory toxicology and research purposes. epiCS (previously known as EST-1000) is an epidermal model that can be used for regulatory toxicity testing (OECD TG 439). CellSystems also offers a wide range of services, including contract research, in vitro assay development and in vitro toxicological testing.

Cellular Dynamics manufactures human induced pluripotent stem cells (iPSCs) and custom iPSCs and iCell® products. The products can be used for drug discovery and screening, testing the safety and efficacy of small molecule and biologic drug candidates, stem cell banking and researching cellular therapeutics.

Centrillion Biosciences provides sequencing, high-throughput genotyping, and bioinformatics services. Cerep offers more than 630 validated in vitro pharmacological assays that cover a broad range of targets, including receptors, ion channels, transporters, enzymes and second messengers, customised assay development service and large-scale profiling using the Bioprint® database.

ClinWorld provides in vitro pre-clinical research and testing for evaluating toxicity (including dermal, ocular, cytotoxicity and genotoxicity studies) and efficacy.

CN Bio Innovations, Ltd., provides human biomimetic platforms for the testing and development of therapeutics for serious human diseases, including the LiverChipTM multi-well three-dimensional liver cell co-culture.

Corning Life Sciences provides in vitro drug-drug interaction testing and ADME services, including enzyme induction, enzyme inhibition and transporter interaction testing.

Cultex® Laboratories provides in vitro toxicological analysis of airborne substances, such as gases, particles, volatile compounds and complex gas mixtures at the air-liquid interface to simulate realistic atmospheric conditions (indoor and outdoor).

Cutest Systems, Ltd., produces customised safety and efficacy dermatological tests for cosmetics, toiletries, over-the-counter preparations and dermatological products, with innovative capabilities in protocol design and clinical trial execution.

Cyprotex provides high-throughput ADME screening and customised ADME assays, in silico pharmacokinetics modelling, in vitro toxicology, endocrine disruption services, personal care and cosmetics industry services, chemical industry services, integrated drug discovery services and physicochemical profiling services. One in vitro skin sensitisation assay offered in-house is the SenCeeTox assay, which incorporates MatTek’s EpiDerm tissue and can therefore be used to test insoluble substances and finished cosmetics products (e.g., solids, polar and nonpolar medical device extracts, gels and creams).

Cytox provides biological testing of medical devices, cosmetics, textiles, laquers and consumer products. Tests include cytotoxicity tests, skin irritation tests, epithelial tissue cultures, use of luminescent bacteria and photometry/ELISA applications.

Dermal Technology Laboratory, Ltd., conducts percutaneous dermal absorption studies (OECD TG 428) that are needed as part of the safety testing of new and existing chemicals, agrochemicals, personal care and pharmaceutical products. The company is also involved with the research and development of new products aimed at improving the delivery of drugs into and through the skin using novel formulation technology, such as the in vitro epidermis screening test (INVEST).

Dermatest Pty, Ltd., conducts SPF, UVA, water resistance, phototoxicity and skin lightening tests, among others, for skin care and sunscreen products.

EDI GmbH focuses on the in vitro characterisation of substances under in vivo-like conditions using complex culture systems that combine primary organ cells and tissues with whole blood to approximate interactions with the human immune system.

EggCentris offers a collection of in vitro bioassays to screen for effects on female and male fertility, endocrine disruption and embryo development and toxicity, biocompatibility testing for medical devices and biomarkers for steroid quantification. Empiriko provides proprietary Biomimiks™ technology that mimics in vivo metabolism, serving as “chemosynthetic livers” for predicting metabolism patterns, pathways and profiles. This technology can be used to rapidly test and select drug candidates (in vitro) and measure drug-to-drug interactions using biological fluids (ex vivo).

Emulate develops organs-on-chips technology to better understand how different diseases, medicines, chemicals, and foods may affect human health.

Entelos, Inc., uses in silico technology to simulate the systems biology of virtual human patients, animals and populations to quantify and predict clinical outcomes. PhysioLab® models are detailed systems biology frameworks for the modelling of relevant patient phenotypes, physiology, pathways and therapeutic interventions.

Enthalpy Analytical, Inc., is a tobacco testing laboratory that performs smoke analyses and tobacco constituent testing for cigarette filler, e-cigarette cartridges, and other tobacco products.

Epithelix Sárl manufactures and sells human tissue for use in in vitro testing. It specialises in respiratory tissues, with its main product being MucilAir™, a three-dimensional human airway epithelia construct. The company offers MucilAir samples to labs that wish to see how well they work in testing applications. It also provides contract testing for various acute and chronic in vitro studies, including inhalational toxicity and drug delivery testing.

Exiqon primarily manufactures custom oligonucleotides and detection probes and offers microarray and PCR-type services (with emphasis on miRNA). It has a specialty division that aims to help pharmaceutical companies design experimental approaches, including developing specific assays, diagnostics and biomarkers. It performs data analysis for those projects as well as validates methods developed for specific needs.

Expression Analysis conducts gene expression profiling and genotyping assays and provides DNA and RNA sequencing and bioinformatics services. Platforms used include the Affymetrix GeneChip® platform, among others. Acquired by Quintiles.

Genetic Resources Core Facility provides equipment and services for use in human genomics studies, including cell culture and cell line establishment. It also assists with project design and custom assay development. Based at the Hopkins School of Medicine in Baltimore.

Genetica provides a range of DNA testing services and cell line authentication, including mycoplasma contamination tests for cell cultures.

Gentronix provides genotoxicity screening tests and services. Some of its patented screens offer the ability to detect all known classes of genotoxin. For compounds that show genotoxicity, the company offers chemistry consulting services on reducing genotoxicity early in product discovery.

Gnarus Systems, Inc., offers companies direct access to proprietary predictive toxicology categorical structure-activity relationship (cat-SAR®) tools and conducts these assessments for companies. Its computational methods are open, not black-box.

HemoGenix, Inc., a contract testing laboratory for the biopharmaceutical industry, focuses on testing new drug candidates for their effect on stem and other primitive cells of the blood-forming system. The laboratory provides high-throughput screening and testing using human-relevant in vitro assays, with a partial focus on in vitro predictive toxicity testing tools (e.g., hemotoxicity, immunotoxicity and drug- drug interaction). Most of the assays developed by HemoGenix are available as assay kits for in-house use. It also offers numerous online training and informational videos and hosts free webinars. HemoShear, LLC, develops cell culture systems that replicate in vivo hemodynamic forces for drug discovery and development with increased human relevance.

Hepregen Corporation sells multi-species (human, dog, nonhuman primate) cellular co-culture kits for drug metabolism, pharmacokinetic, and predictive and mechanistic toxicology testing outside of in vivo systems. Kits can be sold for use, or Hepregen will perform these assays for companies.

Human HepCell offers pre-clinical testing that focuses on liver pathologies based on human tissue-based models.

Hµrel Corporation researches, develops, and commercialises products and services based on cell-based tissue constructs composed of primary cells of the human or other species as well as its patented microfluidic devices that further enhance the already high functionality and range of application of its cell-based in vitro models. Products include hepatic co-culture models of the human, dog, rat and other species.

Imagen Biotech focuses on phenotypic high-content screening and spheroid culture with an interest in personalised medicine and personalisation of cancer chemotherapy.

INDIGO Biosciences, Inc., provides nuclear receptor screening services and kits, mostly for drug discovery, and will develop custom assays where needed.

In Vitro International is a provider of nonanimal testing methods, including the Corrositex method to assess skin corrosion (OECD TG 435).

InSphero AG develops three-dimensional scaffold-free microtissues for pre-clinical screening and drug discovery and testing. Pre-made, characterised microtissues can be purchased in pre-loaded 96 well plates, or researchers can produce their own. The microtissues are useful in a variety of applications, including chronic toxicity testing, cancer research and disease modelling.

Institute for In Vitro Sciences is a nonprofit research and testing laboratory whose offerings include ocular irritation (OECD TG 437), cytotoxicity (OECD TG 432), percutaneous absorption (OECD TG 428), dermal irritation (OECD TG 439), dermal corrosion (OECD TG 431 and 435) and dermal sensitisation testing. The Institute for In Vitro Sciences also has an extensive education and outreach program, including its International Outreach Program.

International Institute for the Advancement of Medicine provides donated organs and tissues for research and education through partnerships with organ procurement organizations, tissue banks, hospitals, and individual donors.

IOMICS Corporation is an analytics company that offers The FUSION Analytics Platform, a software platform for building sophisticated in silico models to test compound response hypotheses.

J-TEC (Japan Tissue Engineering Co., Ltd.) cultures human tissues such as skin and corneal models for use in in vitro research applications.

Kinexus Bioinformatics Corporation uses an integrated platform of proteomics and bioinformatics services for drug discovery. It sells antibody microarray kits aimed at identifying signal transduction changes and other biomarkers of interest in drug discovery, and it offers immunohistochemistry services for tissue and cell samples. Kirkstall, Ltd., produces cell culture chambers that can be connected in a modular fashion using flow of media to create physiologically-relevant conditions for in vitro cell culture. Their chambers come in multiple formats, including air-liquid interface chambers.

Kiyatec, Inc., specialises in providing advanced, three-dimensional cell-based assays and diagnostics with superior physiologic relevance for more accurate ex vivo prediction of patient response to drugs. Kiyatec is also developing robust phenotypic cell-based cancer diagnostics using viable tumour biopsies to assess patient-specific responses to available therapeutic agents.

Leadscope, a chemoinformatics platform, offers a suite of tools allowing researchers integrated access to chemistry-based data mining, visualisation and advanced informatics techniques (prediction tools, scaffold generators, etc.). The platform, coupled with Leadscope’s content databases, is a comprehensive in silico discovery solution.

Lebrun Labs LLC conducts nonanimal toxicology and product safety assay services including testing for ocular irritation and corrosion (OptiSafeTM and bovine corneal opacity and permeability test method), dermal irritation and corrosion (reconstituted human epidermis), and acute oral toxicity (3T3 neutral red uptake assay).

Lhasa Limited, a not-for-profit organisation and educational charity, facilitates collaborative data sharing projects in the pharmaceutical, cosmetics and chemistry-related industries. Lhasa Limited draws on more than 30 years of experience to create user-friendly, state-of-the-art in silico prediction and database systems for use in metabolism, toxicology and related sciences.

Melaka Biotechnology Corporation offers a wide range of testing services in the field of biotechnology, chemistry, toxicology, halal science and microbiology for the pharmaceutical and healthcare industries.

Marin Biologic Laboratories, Inc., is a contract laboratory that provides collaborative and custom research, testing and manufacturing services for the biotechnology, pharmaceutical, cosmetic, diagnostic and agricultural industries.

MatTek Corporation produces human-derived three-dimensional tissue models, including EpiOral, EpiGingival, EpiOcular, EpiAirway, EpiAlveolar, EpiAirway, EpiIntestinal, EpiVaginal, and EpiDerm. The EpiDerm model has been validated for use in the assessment of skin corrosion and irritation (OECD TGs 431 and 439, respectively).

Metalife AG a bioinformatics company dedicated to enabling the life science industry to improve its productivity through integrative bioknowledge solutions. Metalife AG transforms abundant amounts of information into valuable knowledge by semantic data integration, text mining and high-level data analysis.

MicroCoat Biotechnology GmbH a biotechnology company with more than 18 years of experience in the coating of solid phases, kit manufacturing and diagnostic testing. In close cooperation with its customers, MicroCoat develops tailored components, such as coated microplates, antigens and antibody conjugates as a basis for diagnostic kits. MicroCoat provides laboratory services, including assay development, assay validation and sample testing on various technology platforms. If required, laboratory services can be performed under Good Laboratory Practices (GLP) regulations.

Minucells and Minutissue Vertriebs GMBH produces culture systems used to generate differentiated cells and specialized tissues. Nano3D Biosciences operates in the general arena of cell culturing. It developed the Bio-Assembler™ for three-dimensional, in vitro cell culturing, which can be used in the fields of toxicology screening, drug discovery, and regenerative medicine. The Bio-Assembler™ combines nanoparticle-based Nanoshuttle- PL with magnetic fields designed to levitate cells and provide the three-dimensional cell growth environment.

Organovo designs and creates functional human tissues using its proprietary three-dimensional bioprinting technology. Organovo’s goal is to build living human tissues that are proven to function like native tissues. Organovo is constructing a number of three-dimensional tissue models for research and drug discovery applications as well as building human tissues for surgical therapy and transplantation.

Oroxcell offers a broad spectrum of technologies for assessing Absorption, Distribution, Metabolism, Excretion and Toxicity (ADMET) and in vitro toxicity assays to meet regulatory demands and provide a rapid source of relevant information.

Phenion GmbH & Co KG manufactures the Phenion® Full-Thickness Skin Model, which consists of both an epidermis, the outermost layer of the skin, and the underlying dermis made of human primary cells.

Pion, Inc., provides analytical services for the pharmaceutical industry. Analytical measurements and in- depth data analysis are performed using instrumentation parameters tailored specifically for each compound. Pion Biopharma Services’ core expertise is in solution chemistry and absorption/distribution properties of small molecules.

Plexpress provides TRAC (Transcript Analysis with the aid of Affinity Capture) gene expression analysis technology, which combines high-sample throughput with gene multiplexing in a fast and cost-effective workflow. TRAC is a novel method of gene expression analysis, enabling multiplex detection of target gene transcripts from a large number of samples in a single assay.

ProImmune, Ltd., provides unique solutions for pre-clinical and clinical immunology research including a comprehensive antigen characterisation platform, and products and services for tracking antigen-specific immune responses.

Puracyp research is focused on high-volume screening of new chemical entities to identify potential inducers of P450 enzymes and ABC transporters. Puracyp’s nuclear receptor activation service utilises either stably integrated cell lines or transiently transfected cells harbouring P450 enhancer elements in reporter gene constructs and human or animal nuclear receptors, including the Pregnane X Receptor (PXR) and Constitutively Activated Receptor (CAR).

QFAB Bioinformatics (Queensland Facility for Advanced Bioinformatics) provides bioinformatics services, such as scientific software development, for researchers to analyse and manage large-scale datasets.

Reinnervate, Ltd., produces three-dimensional scaffold technology that can be used to culture numerous types of cells under human-relevant conditions. In addition to static systems, their technology can be used to create complex co-culture systems under dynamic flow conditions.

ReproCELL Inc., develops stem cell technologies such as human induced pluripotent stem cell-derived cardiomyocytes, neurons, and hepatocytes. Senzagen offers services to classify chemical skin and respiratory sensitizers utilizing their Genomic Allergen Rapid Detection (GARD) assays. These assays (GARD Skin and GARD Air) use genomic biomarker signatures for hazard prediction.

Simcyp, Ltd., offers the Simcyp population-based simulator, which is used by the pharmaceutical industry to model pharmacokinetics and pharmacodynamics in virtual populations and thereby predict drug-drug interactions and pharmacokinetic outcomes in clinical populations.

Simulations Plus develops Absorption, Distribution, Metabolism, Excretion and Toxicity (ADMET) modelling and simulation software, including GastroPlusTM and ADMET PredictorTM.

SkinEthic Laboratories produces human-derived three-dimensional tissue models, including skin, corneal, oral, gingival and vaginal models. SkinEthic’s EpiSkin model has been validated for use in the assessment of skin corrosion and irritation (OECD TGs 431 and 439, respectively).

Stemgent, Inc., sells induced pluripotent stem cells (iPSCs) for use in drug discovery and offers training courses on human iPSC culture techniques.

Stemina offers two human embryonic stem cell-based assays to predict the developmental toxicity potential of test compounds (DevTOX DiscoveryTM and DevTOXqpTM). Stemina is also developing human-based tests that screen compounds for the potential to cause cardiotoxicity.

StratiCELL manufactures three-dimensional human skin models and conducts in vitro safety and efficacy testing for cosmetic, pharmaceutical, chemical and food industries. Safety testing services include skin corrosion, skin irritation, skin absorption, phototoxicity and ocular irritation.

SynDaver™ Labs manufactures synthetic human tissues and body parts, including anatomy models, organ models, and SynDaver™ Synthetic Human, that mimic the mechanical, thermal, and physicochemical properties of live tissue and can serve as replacements for live animals in medical device studies, clinical training, and surgical simulation.

SynVivo, LLC offers a microchip platform with a physiologically realistic microfluidic environment permitting the real-time study of cellular behavior and interactions, drug delivery, and toxicity effects.

TissUse produces a two-organ-chip which models biological barriers and three dimensional organ environments. Micropumps and microfluidic channels interconnect the organs and enable substances to be tested in life-like models. TissUse plans to develop a ten-organ-chip by 2017.

TCS Cellworks, Ltd., provides kits containing cells and reagents for the study of angiogenesis. The V2a “vasculogenesis to angiogenesis” kitTM allows for comprehensive analysis of the angiogenic pathway, including cell activation, proliferation, migration, elongation and anastomosis.

Upcyte, a life science company, specialises in the controlled, scalable propagation and standardisation of human primary cell products. Medicyte has developed unique and proprietary cell proliferation platforms that form the basis for novel cell-based research and drug development tools and future cell therapy products. VaxDesign the MIMIC® (Modular IMmune In vitro Construct) System simulates the human immune system and is capable of predicting efficacy and potential toxicity of new vaccines and immunotherapies in a high-throughput (automated) way.

VITO (Flemish Institute for Technological Research) is a research and contract testing laboratory that maintains Good Laboratory Practices (GLP)-certified facilities for interlaboratory validation studies.

Vitrocell Systems GmbH manufactures exposure systems for in vitro studies of airborne substances, such as gases, complex mixtures, and nanomaterials. Research applications include the study of combustion exhaust, household chemicals and tobacco smoke, among others.

VitroScreen is a research organisation that conducts in vitro pre-clinical and regulatory toxicological services for pharmaceuticals, medical devices, chemicals, cosmetics, nanomaterials, food, biocides and plant protection products.

Xceleron, Ltd., designs clinical studies for pharmaceutical and bio-based products, including the conduct of Phase 0 microdosing clinical investigations for drug development.

Xenobiotic Detection Systems conducts environmental screening bioassays for dioxins and dioxin-like compounds. The XDS-CALUX® reporter gene-based screening bioassay is validated as method 4435 by the United States Environmental Protection Agency for measuring emissions gas, dust, ashes and other cinders, soil sediment and other matrices.

Xenometrix AG services include genotoxicity testing (Ames test), cytotoxicity testing and an assay to screen for estrogenic and androgenic endocrine disruptors.

Zyleris Pharmatech provides high-throughput testing services for topical, transdermal and personal care product development. Services include in vitro human-based nail, eye and skin absorption studies.

Please contact [email protected] to suggest additional in vitro or in silico testing resources.

Disclaimer: Inclusion on this list does not signify an endorsement from the PETA International Science Consortium Ltd.