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Bioanalysis Solutions Life Inspired, Quality Driven LIFE SCIENCES BIOANALYSIS SOLUTIONS LIFE INSPIRED, QUALITY DRIVEN EXPERTISE TECHNOLOGY QUALITY YOUR GLOBAL DRUG DEVELOPMENT ORGANIZATION FOR BIOANALYTICAL TESTING With over 30 years of experience and operating out of our GLP/GCP compliant laboratories. SGS has the expertise to both develop assays from scratch (including LC-MS/MS, immunoassays and cell-based assays) and to support large scale routine sample analyses, from regulatory pre-clinical (toxicology) to early and late clinical studies (Phase I to IV). SERVICES CONTINUOUS FOCUS ON (cytokines/chemokines) in human DEVELOPMENT matrices, methods readily available for SGS Life Sciences can provide clinical sample analysis. bionanalytical testings for drug A dedicated group evaluates assay SGS provides a large list of development from regulatory preclinical requests from a strategic and scientific biomarkers. SGS doubled its to early and late clinical phases point of view. SGS offers more than capacity (lab space, equipment and 700 validated methods that are ready • Method transfer, development staff) within the last two years to for use with very short lead time. and validation for small molecules, develop multiplex immunoassays for biologics, biosimilars and Validation criteria follow guidelines biomarkers screening by therapeutic biomarkers. from FDA area (Mesoscale, Luminex 200 • PK bioanalysis (small molecules, • 2018: Bioanalytical method validation platforms). SGS also invested in the biologics, biosimilars) & 2019: Immunogenicity COBAS®6000 platform for biomarkers • PD bioanalysis (soluble and cellular • EMA (2011) for GLP compliance analysis under GLP/GCP environment, in the ELLA/SimplePlex and the latest biomarkers) • European Reflection Paper (2012) for Meso Scale Discovery plaforms • Immunogenicity testing the GCP compliance. (S600). (screening, confirmatory, titration characterisation and neutralising BIOMARKERS ELISA, RIA, ECLIA, cell-based assay, anti-drug antibody assays) flow cytometry SGS has also actively pursued the • ELISA and multiplex assays for assay development & validation parent, metabolites, biomarkers SGS LIFE SCIENCES of innovative biomarkers, with the SGS Life Sciences enables the • Cell-based assays (cellular support of our clinical teams. SGS medical and health innovators of biomarkers, receptor occupancy, has the expertise to both develop the world to deliver life-changing neutralising anti-drug antibody assays from scratch (including LC- solutions in the quickest, safest assays, immunophenotyping) MS/MS, immunoassays and cell- and most efficient way, helping based assays) and to support large • Hybrid approach LBA/LC-MS/MS improve the lives of many, by scale routine sample analyses, from providing the highest quality regulatory pre-clinical (toxicology) to services, reliable expertise and early and late clinical studies (Phase guidance through our network of I to IV). In parallel, SGS has validated labs conveniently located around several multiplex inflammatory panels the globe. 2 LARGE CAPACITIES FOR ON- INNOVATIVE TECHNOLOGIES • Flow cytometry capabilities TIME DELIVERY operating in a GCP environment • Customized immunoassay (FACS CANTO & Verse) In order to support the bioanalysis of development and validation for • Clotting and chromogenic assays various classes of compounds, SGS New Biological Entities (NBEs) (Diagnostica Stago) offers a large range of techniques and for Pharmacokinetics (PK) and Immunogenicity (ADA) methods, providing rapid high volume WITH THE RIGHT QUALITY bioanalysis: • Biomarkers development • Mass spectrometry: 31 LC-MS/MS and screening by Multiplex • GLP/GCP compliant bioanalytical (Sciex API 4000 to API6500) Immunoassays sites • Waters equipment (Xevo TQ-S) • Peptide quantification and LLOQ • Each site is periodically inspected by the relevant local agency • Immunoanalysis: ELISA, RIA, ECLIA improvement measurements for routine analysis • Complex LC-MS/MS methods for • Inspected by FDA of a variety of molecules including several biomarkers detection in a • 21 CFR Part 11 compliance program single sample therapeutic proteins, monoclonal • Independent QA group (project and antibodies (mAb), antibody-drug • Fast LC analysis and plasma protein facility audits and GLP training) conjugates (ADCs), peptides and binding determination by rapid biosimilars. equilibrium dialysis • Automated sample preparation using • Dried blood spot filter paper robotics (Multiprobe/ TECAN) or technology combined with LC-MS/MS turbulent flow technology (Cohesive) • Hybrid approach LBA/LC-MS-MS for • Large sample storage capacity NBEs combined with bar code system for sample tracking (400 000 samples storage and equivalent backup) 3 HARMONIZED REGULATORY & QUALITY MANAGEMENT SYSTEM BASED ON GCP/GLP CAPABILITIES EUROPE NORTH AMERICA COUNTRY BELGIUM FRANCE SWITZERLAND CANADA Quality Management System GMP/GLP/GCP GLP/GCP GMP/GLP/GCP GMP ISO Standard 17025 - - 9001/13485 US-FDA Registered • • • • US-FDA Inspected • • • • QUALITY MANAGEMENT SGS complies with the requirements of all global regulatory authorities necessary for approval. OUR 6 LAYER SYSTEM: BASED ON GXP PRINCIPLES: GLOBAL REGULATORY AUTHORITIES • Global quality manual Incorporates additional certifications WE WORK WITH INCLUDE: on local levels • Global policies • US FDA • ISO 17025 • Global SOPs • EMA/MHRA • ISO 9001 • Local quality manual • Health Canada • WHO (prequalification scheme) • Local SOPs • Swiss Medic • Site quality documents • ANSM • PDMA (Japan) 4 CAPABILITIES EUROPE NORTH AMERICA COUNTRY BELGIUM FRANCE SWITZERLAND CANADA Method development/transfer • • • • Method validation • • • • PK Bioanalysis • • • PD Bioanalysis (soluble and cellular biomarkers) • • • Immunogenicity testing • • Cell-based assays • • Hybrid approach LBA/LC-MS/MS • • • Discovery (PK, ADA, Immunotox) • 5 FIND US HERE JOIN THE SCIENTIFIC COMMUNITY BELGIUM SWITZERLAND CONNECT ON LINKEDIN • Brussels (Wavre) • Geneva (Plan-les-Ouates) Discover and share current R&D +32 10 42 11 11 +41 22 794 83 74 market news and events including bioanalytical laboratory and clinical research drug development information FRANCE CANADA • Poitiers • Toronto (Mississauga, ON) [email protected] +33 5 49 57 04 04 +1 905 364 3757 www.sgs.com/LinkedInLife www.sgs.com/lifescience With a harmonized network of laboratories across Europe, North America and Asia, the Laboratory Services Team provides regulatory compliant (GLP/GMP and/or ISO) analytical services including: analytical chemistry, microbiology, stability studies, extractables & leachables, biosafety and protein characterization testing. 6 DELIVERING SUSTAINED EXCELLENCE ACROSS OUR ENTIRE GLOBAL NETWORK SGS has always been at the forefront of bringing excellence into the business environment. With OneVision, our global digitalization initiative to create a single, integrated network of testing laboratories, the SGS Life Sciences global network of laboratories delivers a more comprehensive service to their customers, adding value and delivering faster turnaround times. Utilizing the latest technologies, OneVision implements standardized record-keeping processes in all offices and laboratories around the globe. This means, wherever a customer is in the world, they are guaranteed the same high-quality service. TRANSFORMATION HARMONIZATION OPTIMIZATION Implements a fully digitalized Establishes a standardized digital Standardizes all network data global network that interconnects record-keeping platform across the inputting and streamlines systems and laboratories to SGS global network to reinforce processes to generate greater create a modern, forward-looking our commitment to quality service. efficiencies, improve turnaround business structure. times and deliver better customer service. DIGITALIZATION SUSTAINABILITY BUSINESS EXCELLENCE Creates a single, global digitalized Reduces environmental impact Delivers optimal business laboratory network with improved through digitalization, lessening evolution through high-tech system communications between the SGS the need for paper and storage adoption, enabling continuous network and its customers. while delivering greater network improvements. efficiencies. GET TO MARKET QUICKLY, SAFELY & EFFICIENTLY We provide the highest quality services, reliable expertise and guidance through our network of laboratories conveniently located around the globe. DISCOVERY CLINICAL MARKET DISEASE PRECLINICAL ROUTINE CURING PRODUCTION 7 © SGS Group Management SA – 2019 – All rights reserved - SGS is a registered trademark of SGS Group Management SA WWW.SGS.COM.
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