LIFE SCIENCES LABORATORY SERVICES

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1 LIFE SCIENCES LABORATORY SERVICES LIFE INSPIRED, QUALITY DRIVEN RELIABILITY NETWORK QUALITY

2 ANALYTICAL DEVELOPMENT & QUALITY CONTROL TESTING SGS has been offering high quality analytical testing services to the pharmaceutical industry for decades. We perform a wide range of quality control testing services to support drug research, registration and production. Biopharmaceutical companies use many of the same services, SGS delivers customized solutions to accommodate your unique needs. We perform a variety of tests that are client-specific, particularly in the area of analytical chemistry. SGS LIFE SCIENCES SGS Life Sciences enables the medical and health innovators of the world to deliver life-changing solutions in the quickest, safest and most efficient way, helping improve the lives of many. We provide the highest quality services, reliable expertise and guidance through our network of labs conveniently located around the globe. 2

3 INDUSTRY GROUP LEADER IN DOW JONES SUSTAINABILITY INDEX RobecoSAM Gold Class sustainability award winner 4 years in a row Ecovadis Gold Rating Sustainability Performance 3 years in a row RobecoSAM Industry Mover CDP Climate A List 356+ community projects OUR GUIDING PRINCIPLES At SGS, we are guided in all that we do by the values of trust, quality, expertise, reliability, global partnership and integrity; these are the bedrock upon which our organization is built. We also believe that while we are in the business of life sciences, our commitment lies equally in life-saving. This mean taking responsibility for our own operations and practices to ensure we are protecting and preserving all life, in its many forms: PEOPLE ANIMALS PLANET We do not test on weapons or anything that could be used to threaten life. As a cruelty-free organization, we do not conduct any tests on animals. We are an award-winning leader in sustainability and carbon neutral organization. 3

4 WHY TEST WITH SGS LIFE SCIENCES? RELIABLE & ACCURATE RESULTS When it comes to the pursuit of developing life-changing solutions, there s no such thing as one size fits all; our studies are engineered to your unique needs. As a fully accredited, professionally recognized organization, you can rely on us to act as a neutral third party CRO and deliver unbiased results. We guarantee reliable and accurate testing using state-of-the-art facilities, equipment and techniques and offer advanced Early Phase clinical trials: Phase I-IV Clinical Trial Management, Biometrics & Pharmacovigilance Therapeutic area focus: Infectious Diseases, Vaccines, Respiratory QUALITY & COMPLIANCE Pushing the boundaries of innovation can be challenging. Identifying, analyzing and mitigating compliance risks are essential in developing an effective compliance program. With more than 40 years of experience, SGS is a trusted name with a history of excellence in meeting regulatory compliance and bringing projects to market. We have a reputation for clinical & laboratory quality & operational excellence (Harmonized QMS and Validation & Transfer methods, LIMS, Lean). EXPERT GUIDANCE Reduce costs and improve profits by bringing your products to market quickly and safely; let our experienced consulting and project management teams develop a market access strategy with specific tools and tactics to plan, implement, and monitor your stakeholder engagement activities while reducing errors and potentially costly mistakes that can delay bringing your product to market. PARTNERSHIP & GROWTH With a long standing reputation for our integrity, many companies trust SGS as their global drug development partner; our conveniently located network of labs offer an array of integrated services and expertise, providing you with the knowledge, flexibility and ability to scale. Wide-range of laboratories and clinical research infrastructure Size and diverse testing capabilities matching biopharmaceutical and Small molecules needs International network across America, Europe and Asia We provide services along the entire drug development pathway. SGS provides integrated solutions from preclinical activities to Phase I-IV trials, bioanalytical, R&D, characterization, biosafety, and quality control testing of small and large molecules, raw material products and containers. ABOUT SGS SGS is the world s leading inspection, verification, testing and certification company. We are recognized as the global benchmark for quality and integrity. With more than 95,000 employees, we operate a network of more than 2,400 offices and laboratories around the world. GET TO MARKET QUICKLY, SAFELY & EFFICIENTLY DISCOVERY CLINICAL MARKET DISEASE PRECLINICAL ROUTINE PRODUCTION CURING 4

5 SCOPE OF LIFE SCIENCE SERVICES LABORATORY SERVICES Biologics Characterization Biosafety Bioanalysis Quality Control for Small and Large Molecules PRECLINICAL POST- APPROVAL ROUTINE PRODUCTION LABORATORY SERVICES CLINICAL RESEARCH EXPLORATORY DEVELOPMENT CONFIRMATORY DEVELOPMENT TRADE DISTRIBUTION CLINICAL RESEARCH Clinical Trials (Phase I-IV) Regulatory Consultancy Biometrics 5

6 ANALYTICAL SERVICES ANALYTICAL CHEMISTRY Assay and Purity (e.g. Chromatography, Titration, Limit Tests) Identity (e.g. Spectroscopy, Chromatography) Dissolution Test (On Line / Off Line) Pharmaceutical Water Analysis (E.g. TOC) Water Content (Loss on Drying, KF Titration) Disintegration Appearance (e.g. Clarity, Opalescence) ph and Conductivity Osmolality, Osmolarity Melting Point, Boiling Point etc. Viscosity, Rheology Uniformity of Mass MICROBIOLOGY TESTING Microbial Limits Tests Sterility Testing Microbial Contaminant Identification Preservatives Testing And Microbial Challenges Microbiological Assessment of Antibiotics Bacterial Endotoxins Environmental Monitoring Water Systems Validation Production Facility Qualification Cleaning Validation STABILITY TESTING Long Term Stability Studies Short Term, Accelerated Studies Follow-Up Stabilities Photostability Testing All ICH Conditions + Specific Conditions Fully Controlled and Monitored All Systems With 24 H / 7D - Monitoring And Alert System Validated Monitoring System, 21 CFR Part 11 Compliant Back-Up Chambers Available Comprehensive Documentation 6

7 ANALYTICAL SERVICES METHOD DEVELOPMENT & VALIDATION Method Development for Identity, Assay and Purity of Drug Products, APIs and Degradation Products Method Validation According To ICH Guidelines and/or Customer Requirements Verification of Accuracy And Suitability of The Developed Method Development and Validation of Stability Indicating Methods Transfer Lab To Lab Validation Re-Validation COMPREHENSIVE DEVELOPMENT- AND VALIDATION REPORTS Container/ Content Interaction Extractables and Leachables Migration Studies Container Testing (Glass, Plastics, Rubber Closure,Etc.) Identification Classification Limit Tests Biological Tests Heavy Metals Physicochemical Tests Water Vapor Permeation MEDICAL DEVICE TESTING Determination of Bioburden before Sterilization Sterility Testing According to USP And EP of Products and Biological Indicators Test for Endotoxins Cytotoxicity Testing Hygiene Monitoring for The Qualification and Control Of Production Zones Test for Ethylene Oxide Residues Din En ISO

8 BIOLOGIC ANALYTICAL DEVELOPMENT BIOPHARMACEUTICAL TESTING Host Cell Impurity Testing (Residual DNA / Host cell proteins) Cell Line Characterization Cell-Based Assays Biologics Safety Testing Endotoxin, Virus, Mycoplasma Product Characterization Protein Analysis Disulfide Bridge & Post-Translational Modification Analysis Stability Studies BIOANALYSIS SERVICES - LAB TO CLINICAL Mass Spectrometry & Immunoassays Experts Services for Small and Large Molecule Testing in TK, PK and PD Online Clinical Samples Dosing with CPUs Discovery Biomarkers Translated in Clinical Research Immune Function Testing Immunogenicity, Flow Cytometry, Cytokine Multiplexed ELISA Biopharmaceuticals - Cell Characterization Metabolite Profiling and Balance Studies (14C-labelled drug) BIOLOGICS SAFETY TESTING Sterility Direct Inoculation (EP 2.6.1) Filtration Method (EP 2.6.1) Alternative Automatised Method Endotoxins Detection (EP , USP <85>) Cytotoxicity Testing (ISO , USP <87>) Pyrogen Detection (EP , In Vitro Testing) Bacterial Identification Vitek2 Apigallery Virus Testing (EP , 5.2.3, ICH Q5A) In Vitro Adventitious Virus Assays Mycoplasma Testing (EP 2.6.7, FDA) Cell Banks and Raw Materials Cell-Derived Harvests and Final Product Viral Seeds and Harvests Animal Tissue and Cell-Derived Products Purified Drug Substances for PRP Supporting Manufacture of Biologicals: Recombinant Protein Monoclonal Antibodies Viral Vaccines Cell Therapies Gene Therapies BIOPHARMACEUTICAL ANALYSIS LABORATORY SERVICES PRECLINICAL EXPLORATORY DEVELOPMENT Aggregation Analysis (AUC, SEC-MALS, DLS) CONFIRMATORY DEVELOPMENT POST-APPROVAL BIOLOGICS CHARACTERIZATION & BIOSAFETY Amino Acid Sequencing & Analysis (Edman, MS/MS) - Extinction Coefficient Biosafety Testing Cell Bank & Virus Seeds Characterization - Electron Microscopy Studies Characterization & Quantification of Process and Product-Related Impurities Comparability Studies ROUTINE PRODUCTION TRADE DISTRIBUTION Final Product Testing for Residual DNA & Host Cell Protein (by Immunoassay & Mass Spectrometry) FTIR & Fluorescence to Spectrometric Profile (CD, DS) Glycosylation - Monosaccharides, Sialic Acid, Linkage, Glycan Profile, and Site Analysis Higher Order Structures Analysis Isoform & Electrophoretic Patterns LC Patterns (SEC, RP, IEX) Method Development, Optimization & Validation Peptide Mapping by MS - Disulphide Bridge Analysis Stability Raw Material & Bulk Harvest Testing (Sterility. Mycoplasma, Viruses) 8

9 R&D TO BATCH ANALYSIS LABORATORY SERVICES PRECLINICAL EXPLORATORY DEVELOPMENT CONFIRMATORY DEVELOPMENT POST-APPROVAL ROUTINE PRODUCTION TRADE DISTRIBUTION BIOLOGICS CHARACTERIZATION & BIOSAFETY Biologics Safety Testing - Endotoxin, Virus, Mycoplasma Biotherapeutic Characterization (Primary to Quanternary Structure) Cell-Based Assays, Cytotoxicity (ADCC) Cell & Molecular Biology - qpcr Assays Host Cell Impurity Testing & Identification Method Development, Optimization & Validation Protein, Peptide Analysis & Quantification Virology - Cell Bank & Virus Seeds Characterization BIOANALYSIS Bioanalysis - PK/PD MS & Immunoassay - Large & Small Molecules - ADME 14C Trials Biomarkers - Immunogenicity & Neutralizing Antibody Testing QUALITY CONTROL FOR SMALL & LARGE MOLECULES Extractables & Leachables - Container Testing GMP Analytical Chemistry Microbiological Testing - Quality Control Batch Release Stability Studies (ICH) & Storage Utilities Qualification & Monitoring (Gas, Air, Water & Surface) Facilities / Equipment Qualification & Calibration 9

10 CAPABILITIES PER SITE COUNTRY CANADA CANADA USA USA USA LABORATORIES Toronto (Markham) Toronto (Mississauga) Chicago (Lincolnshire) New Jersey (Fairfield) Philadelphia (West Chester) ANALYTICAL CHEMISTRY MICROBIOLOGY STERILITY TESTING STABILITY STUDIES METHOD DEVELOPMENT & VALIDATION EXTRACTABLES LEACHABLES CONTAINER TESTING P P P P P BIOPHARMA METHOD DEV. & VALIDATION P P P P P P P P P P P P P P P P P P BIOPHARMA CHARACTERIZATION BIOPHARMA QC & STABILITY TESTING P P P P P P P P P P P P P P P P BELGIUM Brussels (Wavre) P P P P P P P P P P BELGIUM Brussels (Zellik) P P P P P FRANCE Paris (Villeneuve La Garenne) P P P P P P P FRANCE Poitiers P P P P GERMANY Berlin P P P P P GERMANY Frankfurt (Taunusstein) P P P P P P GERMANY Wiesbaden P P P GREECE Athens P SWITZERLAND Geneva P P P P P P ITALY Florence (Livorno) P P P P P P UK Glasgow P P P P P P CHINA Shanghai P P P P P P P P P INDIA Chennai P P P P P P P INDIA Mumbai (Navi) P P P P P BIOSAFETY BIOANALYSIS BIOLOGICAL ACTIVITY PLANT / EQUIPMENT QUALIFICATION MEDICAL MARIJUANA IN VITRO TOX 10

11 HARMONIZED REGULATORY & QUALITY MANAGEMENT SYSTEM BASED ON CGMP/GLP COUNTRY LABORATORIES QUALITY MANAGEMENT SYSTEM ISO STANDARD US-FDA REGISTERED US-FDA INSPECTED CANADA Toronto (Markham) GMP - CANADA USA USA USA Toronto (Mississauga) Chicago (Lincolnshire) New Jersey (Fairfield) Philadelphia (West Chester) GMP 9001/13485 GMP/GLP 9001 GMP 9001 GMP - BELGIUM Brussels (Wavre) GMP/GLP/GCP BELGIUM Brussels (Zellik) GMP FRANCE Paris (Villeneuve La Garenne) GMP - FRANCE Poitiers GLP/GCP - GERMANY Berlin GMP - GERMANY Frankfurt (Taunusstein) GMP GERMANY Wiesbaden R&D SWITZERLAND Geneva GMP/GLP/GCP - ITALY Florence (Livorno) GMP 9001 UK Glasgow GMP/GLP - CHINA Shanghai GMP INDIA Chennai GMP INDIA Mumbai (Navi) GMP QUALITY MANAGEMENT SGS complies with the requirements of all global regulatory authorities necessary for approval. OUR 6 LAYER SYSTEM: Global Quality Manual Global Policies Global SOPs Local Quality Manual Local SOPs Site Quality Documents BASED ON GXP PRINCIPLES: Incorporates additional Certifications on local levels ISO ISO 9001 WHO (Prequalification Scheme) GLOBAL REGULATORY AUTHORITIES WE WORK WITH INCLUDE: US FDA EMA / MHRA Health Canada 11

12 FIND US HERE AMERICAS CANADA Toronto (Markham, ON) Toronto (Mississauga, ON) USA Chicago (Lincolnshire, IL) New York City (Fairfield, NJ) Philadelphia (West Chester, PA)

13 FIND US HERE EUROPE BELGIUM GERMANY ITALY Brussels (Wavre) Berlin Florence Brussels (Zellik) Frankfurt (Taunusstein) FRANCE Paris Frankfurt (Wiesbaden) de.pharmaqc@sgs.com fr.pharmaqc2@sgs.com GREECE Poitiers Athens bioanalysis@sgs.com life.greece@sgs.com SWITZERLAND Geneva ch.biopharma@sgs.com UK Glasgow biosafety@sgs.com 13

14 FIND US HERE ASIA CHINA Shanghai INDIA Chennai Mumbai

15 YOUR TRUSTED GLOBAL TEAM

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