Laboratory ServiceS at SGS LiFe ScieNce ServiceS

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1 Laboratory ServiceS at SGS LiFe ScieNce ServiceS

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3 LiFe inspired creative SoLUtioNS in biopharmaceutical characterization, analytical DeveLoPMeNt and QUaLity control testing Just as LIFE derives its source from nature s flora and fauna, the Life Science industry finds its inspiration in nature for past and future discoveries. In our industry s constantly evolving world of science and regulation, finding creative solutions is mandatory for success. We find common ground with our clients being Inspired by Life from drug discovery to market to solve these daily challenges in order to save lives. With a strong focus on biologics, SGS Life Science Services mission is to safeguard the quality of medicines by providing professional and independent services in clinical research, analytical development, biologics characterization and quality control testing of pharmaceuticals, biopharmaceuticals and medical devices thereby creating value for our clients, employees, shareholders and patients worldwide. 3

4 A TRULY GLOBAL NETWORK With 1,400 employees, state-of-theart clinical pharmacology units and the world s largest network of GMP compliant laboratories, SGS serves the pharmaceutical, biotechnology and medical device industries across Europe, the Americas and Asia with 26 facilities located in 14 countries. SGS s mission is to safeguard the quality of medicines by providing professional and independent services. The following pages outline the services we perform within our global network and offer to our clients in order to facilitate R&D, analytical development and quality control release of medicines and medicinal products.

5 FROM MOLECULE TO MARKET SGS Life Science Services helps bio/pharmaceutical and medical device companies by providing services along the entire drug development pathway. With over 35 years of experience as a global contract service organization, SGS provides integrated solutions from preclinical activities to Phase I-IV trials, bioanalytical, R&D, characterization and quality control testing of small and large molecules, raw material products and containers. LIFE SCIENCE SERVICES Preclinical Exploratory Development Development Post-Approval Routine Production Trade Distribution LABORATORY SERVICES Bioanalytical Biopharmaceutical R&D/Quality Control CLINICAL RESEARCH Phase I- IIa Phase II- IV

6 LABORATORY SERVICES SERVICES LABORATORY SERVICES Bioanalytical Biopharmaceutical R&D/Quality Control Preclinical Exploratory Development Method Development, Optimization & Validation GMP Analytical Chemistry QC Release Microbiological Testing Stability Studies (ICH) & Storage Post-Approval Environmental Monitoring (incl. Utilities Analysis Gas & Water) Biologics Safety Testing Endotoxin, Virus, Mycoplasma Protein, Peptide Analysis & Quantification (PPB) Product Characterization See page 17 Host Cell Impurity Testing & Identification Antibody Product Analysis Cell-Based Assays Biomarkers Immunogenicity and Neutralizing Antibody Testing Routine Production Bioanalysis PK/PD Mass Spectrometry Large & Small Molecules ADME- 14 C Trials Flow Cytometry Confirmatory Development Extractables & Leachables Container Testing Trade Distribution SERVICES WITHIN OUR NETWORK LABORATORY CAPABILITIES Laboratories Country analytical Chemistry microbiology stability studies method dev. & validation Container testing medical device biopharma testing bioanalysis toronto (Mississauga) Canada - Chicago (Lincolnshire) usa - - new york (Fairfield) usa - - philadelphia (West Chester)* usa brussels (Wavre) belgium paris (Clichy) France - - poitiers France berlin germany Frankfurt (Taunusstein) germany Freiburg* germany geneva* switzerland London (Wokingham)* uk shanghai China Chennai india - - mumbai india - - singapore singapore Kaohsiung taiwan taipei taiwan * SGS M-Scan

7 analytical DeveLoPMeNt and QUaLity control of PHarMaceUticaLS SGS Life Science Services has been offering high quality analytical testing services to the pharmaceutical industry for decades. We offer a wide range of quality control testing services to support drug research, registration, and production. Biopharmaceutical companies also use many of the same services, and SGS has also added new services to accommodate their unique needs (detailed in the following section). We perform a variety of tests that are client-specific, particularly in the area of analytical chemistry. Please enquire for more information about additional tests we perform that may not be listed in this brochure.

8 analytical chemistry SGS provides the professional expertise and regulatory qualifications necessary to perform analytical testing of raw materials, API s, finished products, packaging material and medical devices. Wellequipped state-of-the-art laboratories offer comprehensive testing services according to the pharmacopoeia (e.g. EP, USP, BP, JP) and to customer specifications. chemical and PHySico-cHeMicaL testing Assays (e.g. UV/Vis, IR, AAS, etc.) Chromatographic tests (e.g. HPLC, GC, IC, ICP-MS) Identification of active ingredients and impurities Physical and physico-chemical determinations (e.g. ph, viscosity, melting point, particle size, osmolality and osmolarity, flash point, loss on drying) Limit tests (e.g. heavy metals, ash, anions) Residual solvents (volatile organic compounds [VOC], organic volatile impurities [OVI]) Solid oral dosage QC tests (e.g. disintegration, dissolution, hardness, friability) Sampling and analyses of water for pharmaceutical purpose and controlled process environments (e.g. TOC, conductivity)

9 MicrobioLoGicaL testing SGS is a leader in Microbiology Quality Control testing, providing a complete array of services for the bio/pharmaceutical industry. SGS scientists are published and active on the scientific committees of several organizations. Capabilities range from assessment of microbial contamination to confirmation of antimicrobial activity. SGS facilities meet the demanding cleanliness and engineering requirements of microbiological testing programs. Class 100 hoods, clean rooms and isolators are available for microbial evaluation. biological and MicrobioLoGicaL ServiceS Microbial limits tests Sterility testing Microbial contaminant identification Mycoplasma testing Preservatives testing and microbial challenges Microbiological assessment of antibiotics Bacterial endotoxins Sampling and analysis of water for pharmaceutical purposes Chemical disinfectant testing and cleaning studies Environmental monitoring Microbiological attribute studies (barrier testing: packaging, condoms, medical gloves; hygienic and antibacterial test: contact lenses, personal care products, etc.) Particulate testing Closure integrity testing

10 container testing SGS Life Science Services is an industry leader in Container Testing (USP, EP, JP, BP), providing full packaging testing for the drug industry. The safety and efficacy of any pharmaceutical product is inextricably linked to its packaging. Containers or closures that do not meet the physical, chemical, or biological specifications of the major compendia will compromise the quality of the drug product. tests include MateriaLS USeD For the MaNUFactUre of containers Identification Limit tests Impurities Assays container testing (GLaSS, PLaSticS, rubber closure ) Classification Identification Limit tests Biological tests Heavy metals Physicochemical tests Water vapor permeation Extractable studies Others container / content interaction 25 C / 40% r.h. 23 C / 75% r.h. Leachables Extractables studies Migration studies Others 10

11 extractables & LeacHabLeS testing The assessment of Extractables and Leachables in bio/pharmaceutical products is an important step in drug product development. Processing equipment, as well as, primary and secondary container closures are potential vectors for chemical contaminants. Monomers and polymer additives such as antioxidants, plasticisers, stabilizers, dyes, metal catalysts and other harmful chemicals may potentially migrate into the product under storage conditions. SGS provides a complete service for testing Extractables in container materials and Leachables in final products. These tests are conducted in cgmp compliant laboratories using technologies that detect ultra trace levels. ServiceS Test strategy planning and data evaluation based on the available information Development of a tailored study design for Extractables and Leachables Extractables profiling (inorganic and organic extractables) Sequential extractions and alternative extraction techniques for isolating Extractables in container materials Characterization of Extractables by chromatographic and spectroscopic investigations Determination of the Analytical Estimation Threshold (AET) Calculation of the Qualification Threshold based on Safety Concern Threshold (SCT) Method development and validation of potential Leachables in pharmaceutical products Performing of Leachables studies on pharmaceutical products Reporting and evaluation of results within the current guidelines technologies HPLC-MS/MS, HPLC Q-Tof, HPLC-UV, DAD HS-GC, HS-GC-MS GC (FID, ECD, FID-NP), GC-MS GC-TEA (nitrosamines) ICP-OES, ICP-MS, AAS, IR FTIR TGA, DCS X-ray fluorescence analysis ASE (accelerated solvent extraction) Soxhlet

12 StabiLity StUDieS From study design to storage, monitoring, analytical testing and documentation, SGS offers services to your complete satisfaction. With more than 20 years of experience and currently more than 100,000 samples in storage, SGS has the skills and the capacity to handle your stability projects. SGS can provide its customers with the complete bandwidth of storage conditions in numerous climatic walk-in chambers and climatic cabinets with a total storage capacity of approximately 1,300 m 3. Various refrigerators and freezers are available for storage at lower temperatures. All storage chambers are fully controlled with 24h/7d monitoring and alert systems (21 CFR part 11 compliant). For your safety, SGS operates back up chambers for complete sample retrieval. ServiceS Support in designing studies for real time, stress tests and photo stability studies Development and validation of stability indicating methods Examination of stability-relevant parameters Storage and management of stability samples Interim reports for every testing period Comprehensive final report climatic ZoNeS (according to ich) I. 21 C / 45% r.h. III. 30 C / 35% r.h. II. 25 C / 60% r.h. IV. 30 C / 65% r.h. and / or 30 C/75% r.h. LoNG-terM, intermediate and accelerated StoraGe 25 C / 40% r.h. (semi-permeable container study) 25 C / 60% r.h. 30 C / 65% r.h. 30 C / 70% r.h. 30 C / 75% r.h. 40 C / 75% r.h. 40 C / not more than (NMT) 25% r.h. +5 C 20 C 80 C Photostability Transport stability (freeze and thaw, cycle test) In-use stability Customer-specific conditions

13 MetHoD DeveLoPMeNt & validation SGS Life Science Services laboratories have extensive knowledge and expertise in developing and validating methods for raw materials, API s, finished products and cleaning validation. SGS offers development and documentation of analytical protocols and reports for proprietary and nonproprietary test methods and manufacturing processes in compliance with the ICH Q2 (R1) guideline Validation of Analytical Procedures : Text and Methodology and FDA guidelines. Once a method is validated, it may require transfer. Method transfer may involve comparative testing, co-validation between two sites (Lab-to-Lab), complete or partial revalidation and comprehensive documentation (Transfer Plan, Protocol, Report). Whether SGS Life Science Services is the developing or the receiving laboratory, we can assist you with your method transfer requirements. MetHoD DeveLoPMeNt Identification Assay testing Dissolution Particle size distribution Testing for impurities Stability indicating methods Humidity/temperature Temperature ph variation Oxidative and reductive stress Light stressing Microbial testing validation Accuracy Precision Repeatability Intermediate precision Reproducibility Specificity Detection limit Quantitation limit Linearity Range Robustness System suitability test 13

14 environmental MoNitoriNG In addition to acceptance tests for the installation of clean rooms in production facilities, SGS can perform routine monitoring of viable and nonviable contamination of production facilities. SGS offers a broad range of monitoring services for clean rooms and can also provide you with customized hygiene-monitoring programs that suit your needs. ServiceS include Viable and nonviable particle counting of air sample in manufacturing, packaging and testing sites Microbial sampling and enumeration of surfaces Cleaning validation studies Disinfectant efficacy studies Microbiological tests on individual process media (air, water, technical gases) Determination of bacterial count in air under all operating conditions Particle measurement Determination of TOC (total organic carbon) Media Control (e.g. humidity, particle, oil and organic residues in gases) Testing surfaces, consumables and primary packaging Qualification of production facilities after installation, reconstruction, standstill, etc. Confirmation of personal hygiene, determination of microbiological exposure on clothing and hands of production personnel

15 MeDicaL Device testing SGS supports its partners in the medical device industry with a broad range of services. SGS performs hygienic qualification of the production facilities, microbiological tests on the products before and after sterilization, and screening for possible residual contaminants from the sterilization process (endotoxins, ethylene oxide). SGS also conducts studies for migration of substances from packaging material (leachables). ServiceS include Determination of bioburden before sterilization Sterility testing according to USP and EP of products and biological indicators Method development and validation Endotoxin testing Gel clot, kinetic, and chromogenic Residual ethylene oxide tesing according to EN ISO Environmental monitoring of production zones Viable and nonviable particulate analysis RODAC and swab analysis of surfaces Cytoxicity bioassay Polymer identification FTIP, TGA, DSC Container Closure Permeation Dye and microbial ingress studies Test for leachable substances according to EN ISO These services are complimented by capabilities in other SGS divisions, including CE mark, electrical testing, package integrity testing and Medical Device ISO certification and audits. SGS is the Medical Device indutry s single source provider.

16 REGULATORY AND QUALITY MANAGEMENT SYSTEMS Laboratories Country QuaLity management systems iso standard us-fda registrered us-fda inspected toronto (Mississauga) Canada GMP/GLP - Chicago (Lincolnshire) usa GMP/GLP 9001 new york (Fairfield) usa GMP/GLP 9001 philadelphia (West Chester)* usa GMP - brussels (Wavre) belgium GMP/GLP paris (Clichy) France GMP 9001 poitiers France GLP/GCP - - berlin germany GMP - Frankfurt (Taunusstein) germany GMP/GLP Freiburg* germany GMP/GLP - - geneva* switzerland GMP/GLP - London (Wokingham)* uk GMP/GLP - shanghai China GMP Chennai india GMP mumbai india GMP in preparation - singapore singapore GMP taipei taiwan Kaohsiung taiwan * SGS M-Scan Mumbai Laboratory opened in January 2012 SGS MEANS BIOPHARMACEUTICAL SERVICES SERVICES LABORATORY SERVICES Biopharmaceutical Preclinical Exploratory Development QUALITY Confirmatory Development Method Development, Optimization & Validation Amino Acid Sequencing (Edman, MS/MS) Amino Acid Analysis N- and C-terminal Sequencing Peptide Mapping by MS Post-Approval Routine Production Disulfide Analysis Glycosylation Analysis Oligosaccharide Population (Glycan profile by MS and LC methods) Monosaccharide Composition Analysis Sialic Acid Analysis Linkage Analysis Glycosylation Site Determination Post-Translational Modification Analysis Isoform and Electrophoretic Patterns Extinction Coefficient LC Patterns (SEC, RP, IEX) Spectroscopic Profiles (CD, DSC, NMR) Aggregation Analysis (AUC, SEC-MALS) Characterization of Process and Product-Related Impurities Trade Distribution

17 characterization of biopharmaceuticals The analysis of biopharmaceuticals such as recombinant proteins and glycoproteins, monoclonal antibodies or nucleic acid-based drugs, requires a different skill set than that for small chemical entities. Many of the analytical techniques such as LC/MS/MS and capillary electrophoresis or quantitative PCR have emerged from an R&D-type setting into routine use for product characterization. Nevertheless, the same demanding quality standards apply for the quality control of biologicals as for small molecule drugs. With the recent acquisition of M-Scan in November 2010, SGS enhances its service portfolio for the characterization of biologics with GLP/GMP contract analytical services, consultancy and training based on high-end mass spectrometry, chromatography and physicochemical analyses.

18 cell LiNe characterization SGS uses a variety of nucleic acid and protein-based technologies to characterize the identity of cell lines and assess the structure of the expression construct. According to ICH guideline Q5B, the characterization of the expression construct is important to ensure the consistent production of a recombinant DNA-derived product. The analysis should establish that the correct coding sequence of the product is incorporated into the host cell and is maintained during culture to the end of production. test MetHoDS Gene and plasmid copy number assay Flow cytometric analysis (FACS Canto II) Histocompatibility antigens Southern blotting DNA fingerprinting DNA sequencing SaFety testing Adventitious virus assay (ICH Q5A) Specific virus/bacteria detection by qpcr Virus titration by plaque assay Haemaglutination / haemadsoption assay Mycoplasma testing according to Eur. Ph and FDA guidelines Culture method Indicator cell method qpcr method Sterility testing Direct inoculation Filtration method Alternative qualified system: BactT/Alert 3D Bacterial endotoxin testing Detection of Host residual contaminents: Residual generic DNA/RNA Host specific residual DNA HCP assay

19 HOST CELL IMPURITY TESTING SGS provides you with sufficiently sensitive test methods to detect host cell impurities. Additionally, SGS has the capabilities to develop specific host cell protein assays for your expression cell line. Host cell proteins (HCPs) comprise the major protein contaminants associated with biopharmaceuticals derived by recombinant DNA technology. Protein recovery processes are required to minimize the content of HCPs in the final product. Host cell proteins are often immunogenic and can alter the therapeutic efficacy of a drug or can affect patient safety. Host cell DNA levels are another cellular contaminant present in biopharmaceuticals. The WHO, the EU and the FDA have set specific levels of residual host cell DNA that are acceptable in biopharmaceutical products. SGS has the expertise to develop and validate specific methods for specific product or purpose. SERVICES INCLUDE : HOST CELL PROTEIN ASSAYS ELISA ILA (Immunoligand Assay) SDS-PAGE Immunoblotting HCP assay (kit-based) Flow cytometric analysis HOST CELL DNA ASSAYS Quantitative PCR Flourescence assays (OliGreen and PicoGreen ) ANALYSIS OF CELL CULTURE - DERIVED IMPURITIES Albumin Nutrients

20 biologics SaFety testing SGS s Biologics Safety Testing detects contamination of cell cultures, virus stocks and final products, with a view to assisting quality control measures in the development of biopharmaceutical products. The threat of contamination of cell cultures by adventitious agents such as, endotoxin, viruses, and mycoplasma, should not be underestimated. For instance, endotoxins, which when present in a final product, can induce an inflammatory response in patients. Viral contamination can lead to unreliable experiments in biomedical and biotechnological research and bring about significant productivity losses in biological manufacturing. Finally, mycoplasma can alter virtually every cellular process, including hybridoma selection rates, protein and nucleic acid synthesis, and immunogenicity and chromosomal damage. Our services therefore test for a range of contaminants at any stage of drug development and production. endotoxin test MetHoDS LAL gel clot assay LAL photometric assay LAL colorimetric assay virus testing EP and and ICH Q5A In vitro adventitious virus assays by CPE, haemadsorption, and haemaglutination assay Virus titration by plaque assay Customer-specific method development tests For MycoPLaSMa DetectioN Cell culture method (21 CFR and EP 2.6.7) Indicator cell Fluorochrome staining Validated PCR based method with preenrichment or direct detection SaMPLe MateriaLS Biopharmaceutical samples, including: raw materials, intermediate products, API, bulk drugs, and finished products Working and master cell banks Culture media Conducted by our network of international experts, whose skills and knowledge are second to none, our biopharma safety testing methods are complaint with FDA, USP, EP and ICH guidelines, and also help you to ensure that your biopharmaceutical products meet other international and local regulatory requirements.

21 PoteNcy assays Cells-based assays are designed to test the effectiveness of potential drug candidates and measure the effects on indicator cell lines. Below are some examples of cell-based potency assays performed by SGS. Since assays will vary depending upon the drug candidate of interest, please consult with your SGS Representative regarding custom-designed assays. cell GroWtH assays Study Design Evaluate the potency of a specific growth factor Scope of SGS work SGS develops all protocols and designs in vitro bioassay (cell line selection, synchronised culture, selection endpoints). Provide client with final report. Measurable assay endpoints: Measure of cell proliferation by MTT assays interleukin ProDUctioN Study Design Evaluate the potency of an expression vector (Bacteria) to produce IL-x Scope of SGS work Transfer and Validation of the method Provide client with final report Measurable assay endpoints: IL-x specific ELISA viral inhibition by ifns Study Design Evaluate the potency of IFNs Scope of SGS work Cell line and virus selection Design the in vitro bioassay Provide client with final report Measurable assay endpoints: Cell Viablility by MTT assay identification of contaminant cells Study Design Identification and quantitation of contaminant cells in a Cell Therapy product Scope of SGS work Biomarker identification and Antibody selection Flow Cytometry set-up Provide client with final report Measurable assay endpoints: Cell detection and quantitation by FACS

22 ProteiN characterization SGS has the necessary expertise and experience to perform the analysis of your peptides, (glyco)proteins, and antibodies. A broad portfolio of analytical test methods ranging from classical gel electrophoresis and various chromatographic methods to the latest mass spectrometric techniques are available. SGS provides a full analysis package for physicochemical characterization to fulfill ICH Q6B requirements. In addition, the experts at SGS will help you check for purity and homogeneity of your protein, identify processand product-related impurities, analyze post-translational modifications, including glycosylation patterns, detect aggregation complexes (especially important in antibody formulations), and test for the biological activity. test MetHoDS ProteiN identity Peptide mass mapping Amino acid analysis Disulfide bridge assignment Intact protein mass determination Sequence confirmation, including N-and C-terminal (LC/MS/MS) Post-Translational modification analysis (phosphorylation, etc.) Methionine oxidation status Antibody typing and subclass analysis PEGylation status Isoform and electrophoretic patterns Western blotting ProteiN PUrity RP-HPLC (UV, ELSD, fluorescence) IE-HPLC SEC-HPLC SDS-PAGE (reduced, non-reduced) cief N-terminal sequencing (Edman) Variants analysis (LC/MS/MS) Degradation products/stability (LC/MS/ MS, DSC, CD) ProteiN/ antibody aggregation analysis HPLC-SEC, SEC/MALS, UV, RI, and MS Analytical ultracentrifugation (AUC) SDS-PAGE biological activity ELISA Bioassays Detection of glycerides (tri-, di-, mono-, glycerol) Protein concentration

23 Erythroprotein Tamm-Horsfall glycoprotein Glycodelin S Glycodelin A ProteiN GLycoSyLatioN analysis Glycosylation analysis plays an important role in establishing the safety and efficacy of final drug products and, as such, is an essential part of SGS s analysis portfolio. Highlighting where factors such as cell line and bioreactor conditions have affected the structure, linkage or composition of glycans within a protein, it is also a key tool in helping to protect your business s reputation for high-quality products. At SGS, we have shaped our Protein Glycosylation Analysis services to meet the requirements of ICH 6QB, so you can be sure you are meeting regulatory expectations. Our experts are always at hand to give advice on what may be most appropriate strategies for your products, whether you are using glycosylation screening for drug discovery (cell line selection) or at any stage of the drug manufacturing process. No matter what your glycoprotein analysis needs, we offer a commitment to quality and apply international expertise at a local level. ServiceS Monosaccharide composition analysis: Confirms the presence of carbohydrate (neutral, amino and acidic species) in a product Glycan population analysis: Provides a detailed picture of N- and O-linked glycan structures Glycan antennary profiling analysis (including linkage analysis): Information on structure including multiantennary or bisected N-glycans Glycosylation site analysis: Glycans at individual sites on the protein can be isolated and studied techinques GC-MS LC-MS MALDI-MS ES-MS HPAEC-PAD HILIC-FLD, HILIC-FLD-MS

24 antibody * ProDUct analysis SGS is one of the world s most trusted experts for independent biopharmaceutical analysis. Clients using our Antibody* Characterization Services benefit from our vast experience gained from analyzing hundreds of biotechnology products. Whether you need antibody analysis to support drug discovery or the drug manufacturing process, we offer tailor-made solutions based on your particular business requirements. Our services can be an individual analysis or a comprehensive package. SGS s antibody sequencing and analysis is carried out to the high standards demanded by our global quality assurance network and the requirements of FDA, EMA and ICH guidelines. Contact us today to discuss how you can draw on our international expertise for your antibody analysis needs to help reduce time to market. ServiceS Amino acid sequence analysis (Edman and MS/MS) Amino acid composition analysis and determination of extinction coefficient N-terminal and C-terminal amino acid sequencing Peptide mass mapping Disulfide bridge analysis assignment A range of carbohydrate structure analyses including: monosaccharide composition oligosaccharide profiling linkage analysis glycosylation site determination Determination of intact molecular weight Electrophoretic and isoform patterns Liquid chromatographic patterns Identification of post-translational modifications Spectroscopic profiling (CD, NMR) Identification of degradation-related product impurities including: Deamidation Oxidation Protein aggregation assessment (AUC, SEC/MALS, DSC) Immuno and cell-based assays * Antibody and Antibody-related (e.g. fragments)

25 bioanalysis With over 20 years of experience, and its two GLP certified and FDA inspected labs, SGS has an international reputation for complex method development and validation as well as for the analysis of drugs in biological fluids. SGS has the expertise to both develop assays from scratch (including immunoassays) and to support large scale sample analyses, from pre-clinical and clinical studies. To support the bioanalysis of various classes of compounds, SGS offers over 600 validated techniques and methods. (visit Exceptional sample processing and analytical capabilities, combined with scientific expertise, enable SGS to provide clients with rapid high-volume bioanalysis: ServiceS In vitro models (cell-based bioassays) ADME ( 14 C-based analysis) Pre-clinical development Early to late phase clinical trials Biomarkers Immunogenicity testing and analysis of biological products Marketed drugs (interactions & reformulations) testing MetHoDS High throughput mass spectrometry: 31 LC/MS/MS, including UPLC with a PDA detector; dried blood spot preparation capabilities Automated sample preparation using robotics (Multiprobe) and turbulent flow technology Complete Immunogenicity testing Screening, confirmatory, characterization and neutralizing antibody assays ELISA, RIA, ECL, cell-based assay, flow cytometry Quantification of therapeutic biologicals and associated biomarkers for PK/TK studies

26 SGS MEANS PROXIMITY AMERICAS CANADA Toronto (Mississauga, ON) USA Chicago (Lincolnshire, IL) New York (Fairfield, NJ) Philadelphia (West Chester, PA) EUROPE BELGIUM Brussels (Wavre) FRANCE Paris (Clichy) Poitiers GERMANY Berlin Frankfurt (Taunusstein) Freiburg SWITzERLAND Geneva UNITED KINGDOM London (Wokingham) ASIA CHINA Shanghai INDIA Chennai Mumbai SINGAPORE Singapore TAIWAN Kaohsiung Taipei VISIT SGS.COM/PHARMAQC

27 CONTACT US SGS LIFE SCIENCE SERVICE LOCATIONS EUROPE BELGIUM (WAVRE) FRANCE (CLICHY) fr.pharmaqc@sgs.com FRANCE (POITIERS) clinicalresearch@sgs.com GERMANY (BERLIN) de.pharmaqc@sgs.com GERMANY (FREIBURG) de.m-scan@sgs.com GERMANY (TAUNUSSTEIN) de.pharmaqc@sgs.com SWITzERLAND (GENEVA) ch.m-scan@sgs.com UK (WOKINGHAM) uk.m-scan@sgs.com ASIA INDIA (CHENNAI) in.pharmaqc@sgs.com INDIA (MUMBAI) in.pharmaqc@sgs.com SINGAPORE (SINGAPORE) sg.pharmaqc@sgs.com CHINA (SHANGHAI) cn.pharmaqc@sgs.com TAIWAN (TAIPEI / KAOHSIUNG) ext 2500 tw.pharmaqc@sgs.com NORTH AMERICA CANADA (MISSISSAUGA) ca.pharmaqc@sgs.com USA (FAIRFIELD, NJ) us.pharmaqc@sgs.com USA (LINCOLNSHIRE, IL) us.pharmaqc@sgs.com USA (WEST CHESTER, PA) us.m-scan@sgs.com

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