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LIFE INSPIRED, QUALITY DRIVEN LIFE SCIENCES LABORATORY SERVICES

LIFE SCIENCES LABORATORY SERVICES · the area of analytical chemistry. SGS LIFE SCIENCES SGS Life Sciences enables the medical and health innovators of the world to deliver life-changing

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LIFE INSPIRED, QUALITY DRIVEN

LIFE SCIENCES

LABORATORY SERVICES

2

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.

ANALYTICAL DEVELOPMENT & QUALITY CONTROL TESTING

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OUR GUIDING PRINCIPLESAt 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.

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

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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.

WHY TEST WITH SGS LIFE SCIENCES?

DISEASE

DISCOVERY

PRECLINICAL

CLINICAL

ROUTINE PRODUCTION

MARKET

CURING

GET TO MARKET QUICKLY, SAFELY & EFFICIENTLY.

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SCOPE OF LIFE SCIENCE SERVICES

CLINICAL RESEARCH

LABORATORY SERVICES

• Biologics characterization

• Biosafety

• Bioanalysis

• Quality control for small and large molecules

CLINICAL RESEARCH

• Clinical Trials (Phase I-IV)

• Regulatory Consultancy

• Biometrics

LABORATORY SERVICES

PRECLINICAL

EXPLORATORY DEVELOPMENT

CONFIRMATORY DEVELOPMENT

TRADE DISTRIBUTION

POST-APPROVAL

ROUTINE PRODUCTION

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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

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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 10993-7

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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 2.6.14, USP <85>)

• Cytotoxicity Testing (ISO 10993-5, USP <87>)

• Pyrogen Detection (EP 2.6.30, In Vitro Testing)

• Bacterial Identification

• Vitek2

• Apigallery

• Virus Testing (EP 2.6.16, 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

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BIOPHARMACEUTICAL ANALYSIS LABORATORY SERVICES

PRECLINICAL EXPLORATORY DEVELOPMENT

CONFIRMATORY DEVELOPMENT POST-APPROVAL ROUTINE

PRODUCTIONTRADE

DISTRIBUTION

BIOLOGICS CHARACTERIZATION & BIOSAFETY

Aggregation Analysis (AUC, SEC-MALS, DLS)

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

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

High Order Structures Analysis

Isoform & Electrophoretic Patterns

LC Patterns (SEC, RP, IEX)

Method Development, Optimization & Validation

Peptide Mapping by MS - Disulphide Bride Analysis

Raw Material & Bulk Harvest Testing (Sterility. Mycoplasma, Viruses)

Stability

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R&D TO BATCH ANALYSIS LABORATORY SERVICES

PRECLINICAL EXPLORATORY DEVELOPMENT

CONFIRMATORY DEVELOPMENT POST-APPROVAL ROUTINE

PRODUCTIONTRADE

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

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COUNTRY LABORATORIES AN

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CANADAToronto (Markham)

P P P P P

CANADAToronto (Mississauga)

P P P P P P P P P P P P

USAChicago (Lincolnshire)

P P P P P P

USANew Jersey (Fairfield)

P P P P P P P P P

USAPhiladelphia (West Chester)

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

FRANCEParis (Villeneuve La Garenne)

P P P P P P P

FRANCE Poitiers P P P P

GERMANY Berlin P P P P P

GERMANYFrankfurt (Taunusstein)

P P P P P P

GERMANY Wiesbaden P P P

GREECE Athens P

SWITZERLAND Geneva P P P P P P

ITALYFlorence (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

LABORATORY CAPABILITIES PER SITE

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QUALITY MANAGEMENT

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 17025

• ISO 9001

• WHO (prequalification scheme)

SGS complies with the requirements of all global regulatory authorities necessary for approval. GLOBAL REGULATORY AUTHORITIES

WE WORK WITH INCLUDE:

• US FDA

• EMA / MHRA

• Health Canada

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COUNTRY LABORATORIES

QUALITY MANAGEMENT

SYSTEM ISO STANDARDUS-FDA

REGISTERED US-FDA INSPECTED

CANADA Toronto (Markham) GMP - • •

CANADAToronto (Mississauga)

GMP 9001/13485 • •

USAChicago (Lincolnshire)

GMP/GLP 9001 • •

USANew Jersey (Fairfield)

GMP 9001 • •

USAPhiladelphia (West Chester)

GMP - • •

BELGIUM Brussels (Wavre) GMP/GLP/GCP 17025 • •

BELGIUM Brussels (Zellik) GMP - - -

FRANCEParis (Villeneuve La Garenne)

GMP - • •

FRANCE Poitiers GLP/GCP - • •

GERMANY Berlin GMP - • •

GERMANYFrankfurt (Taunusstein)

GMP 17025 • •

GERMANY Wiesbaden R&D - - -

SWITZERLAND Geneva GMP/GLP/GCP - • •

ITALY Florence (Livorno) GMP 9001 • •

UK Glasgow GMP/GLP - • •

CHINA Shanghai GMP 17025 • •

INDIA Chennai GMP 17025 • •

INDIA Mumbai (Navi) GMP 17025 • •

HARMONIZED REGULATORY & QUALITY MANAGEMENT SYSTEM BASED ON CGMP/GLP

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FIND US HERE

AMERICAS

CANADA

• Toronto (Markham, ON)

+1 905 305 0998

[email protected]

• Toronto (Mississauga, ON)

+1 905 364 3757

[email protected]

USA

• Chicago (Lincolnshire, IL)

+1 847 821 8900

[email protected]

• New York City (Fairfield, NJ)

+1 973 244 2435

[email protected]

• Philadelphia (West Chester, PA)

+1 610 696 8210

[email protected]

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FIND US HERE

EUROPEBELGIUM

• Brussels (Wavre)

+32 10 42 11 11

[email protected]

• Brussels (Zellik)

+32 22 15 04 01

[email protected]

FRANCE

• Paris

+33 1 41 06 95 93

[email protected]

• Poitiers

+33 5 49 57 04 04

[email protected]

GERMANY

• Berlin

+49 30 3460 7500

[email protected]

• Frankfurt (Taunusstein)

+49 6128 744 245

[email protected]

• Frankfurt (Wiesbaden)

+49 611 962 5910

[email protected]

GREECE

• Athens

+302 105 720 777

[email protected]

ITALY

• Florence

+39 0586 852591

[email protected].

SWITZERLAND

• Geneva

+41 22 794 83 74

[email protected]

UK

• Glasgow

+44 141 952 0022

[email protected]

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FIND US HERE

ASIA

CHINA

• Shanghai

+86 21 6115 2197

[email protected]

INDIA

• Chennai

+91 44 6462 9711

[email protected]

• Mumbai

+91 22 6457 2540-45

[email protected]

YOUR TRUSTEDGLOBAL TEAM

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