SGS LSS Lab Services Brochure en 11

7/24/2019 SGS LSS Lab Services Brochure en 11

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LABORATORY SERVICES ATSGS LIFE SCIENCE SERVICES







A TRULYGLOBALNETWORK

With 1,300 employees, state-of-the-art clinical pharmacology units and theworld’s largest network of GMP compliantlaboratories, SGS serves the pharmaceu-

tical, biotechnology and medical deviceindustries across Europe, the Americasand Asia with 25 facilities located in 14

countries. SGS’s mission is to safeguardthe quality of medicines by providing pro-fessional and independent services.

The following pages outline the serviceswe perform within our global network andoffer to our clients in order to facilitate

R&D, analytical development and qualitycontrol release of medicines and medicinalproducts.



FROM MOLECULE TO MARKET

LABORATORYSERVICES

PreclinicalExploratory

Development DevelopmentPost-Approval

Routine

Production

Trade

Distribution

CLINICALRESEARCH

Bioanalytical

BiopharmaceuticalR&D/Quality Control

Phase

I- IIa

Phase

II- IV

LIFE SCIENCE SERVICES

SGS Life Science Services helps bio/phar-maceutical and medical device companiesby providing services along the entiredrug development pathway. With over 35years of experience as a global contractservice organization, SGS provides inte-grated solutions from preclinical activitiesto Phase I-IV trials, bioanalytical, R&D,characterization and quality control testingof small and large molecules, raw materialproducts and containers.



Preclinical Exploratory Post-Approval Routine

LABORATORY SERVICES

SERVICES WITHIN

OUR NETWORKLABORATORY CAPABILITIES

LABORATORIES COUNTRY ANALYTICALCHEMISTRY

MICRO-BIOLOGY

STABILITYSTUDIES

METHOD DEV.& VALIDATION

CONTAINERTESTING

MEDICALDEVICE

BIOPHARMATESTING BIOANALYSIS

Toronto (Mississauga) Canada • • • • • • • -Chicago (Lincolnshire) USA • • • • • • - -New York (Faireld) 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 • • • • • • - -Singapore Singapore • • • • - • - -Kaohsiung Taiwan • - - - - - - -Taipei Taiwan • • - - - - - -

* SGS M-Scan

Method Development, Optimization & Validation

GMP Analytical Chemistry – QC Release

Microbiological Testing

Stability Studies (ICH) & Storage

Environmental Monitoring (incl. Utilities Analysis – Gaz & Water)

Biologics Safety Testing – Endotoxin, Virus, Mycoplasma

Protein, Peptide Analysis & Quantification (PPB)

Product Characterization – See page 17

Host Cell Impurity Testing & Identification

Cell-Based Assays

Biomarkers – Immunogenicity and Neutralizing Antibody Testing

Bioanalysis – PK/PD Mass Spectrometry – Large & Small Molecules

ADME- 14C Trials

Flow Cytometry

Extractables & Leachables – Container Testing

PreclinicalExploratory

DevelopmentConfirmatoryDevelopment

Post-Approval RoutineProduction

TradeDistributionSERVICES

L A B O R A T O R Y

S E R V I C E S

B i o a n a l y t i c a l

B i o p

h a r m a c e u

t i c a l

R & D / Q u a l i t y

C o n t r o

l

Antibody Product Analysis



SGS Life Science Services has beenoffering high quality analytical testingservices to the pharmaceutical industry fordecades. We offer a wide range of qualitycontrol testing services to support drugresearch, registration, and production.Biopharmaceutical companies also usemany of the same services, and SGS hasalso added new services to accommodatetheir unique needs (detailed in the follow-ing section).

We perform a variety of tests that areclient-specic, particularly in the area ofanalytical chemistry. Please enquire formore information about additional testswe perform that may not be listed in thisbrochure.

ANALYTICALDEVELOPMENTAND

QUALITY CONTROLOFPHARMACEUTICALS



ANALYTICAL CHEMISTRY

SGS provides the professional expertiseand regulatory qualications necessary toperform analytical testing of raw materi-als, API’s, nished products, packagingmaterial and medical devices. Well-equipped state-of-the-art laboratories offercomprehensive testing services accordingto the pharmacopoeia (e.g. EP, USP, BP, JP)and to customer specications.

CHEMICAL AND PHYSICO-CHEMICAL

TESTING

■ Assays (e.g. UV/Vis, IR, AAS, etc.) ■ Chromatographic tests (e.g. HPLC, GC,IC, ICP-MS)

■ Identication of active ingredients andimpurities

■ Physical and physico-chemical deter-minations (e.g. pH, viscosity, meltingpoint, particle size, osmolality andosmolarity, ash point, loss on drying)

■ Limit tests (e.g. heavy metals, ash,anions)

■ Residual solvents (volatile organiccompounds [VOC], organic volatileimpurities [OVI])

■ Solid oral dosage QC tests (e.g. disinte-gration, dissolution, hardness, friability)

■ Sampling and analyses of water forpharmaceutical purpose and controlledprocess environments (e.g. TOC,conductivity)



BIOLOGICAL AND MICROBIOLOGICALSERVICES

■ Microbial limits tests ■ Sterility testing ■ Microbial contaminant identication

■ Mycoplasma testing ■ Preservatives testing and microbialchallenges

■ Microbiological assessment ofantibiotics

■ Bacterial endotoxins ■ Sampling and analysis of water forpharmaceutical purposes

■ Chemical disinfectant testing andcleaning studies

■ Environmental monitoring ■ Microbiological attribute studies (barriertesting: packaging, condoms, medicalgloves; hygienic and antibacterial test:contact lenses, personal care products,etc.)

■ Particulate testing ■ Closure integrity testing

SGS is a leader in Microbiology QualityControl testing, providing a complete arrayof services for the bio/pharmaceuticalindustry. SGS’ scientists are published andactive on the scientic committees of sev-eral organizations. Capabilities range fromassessment of microbial contamination toconrmation of antimicrobial activity. SGS’facilities meet the demanding cleanlinessand engineering requirements of microbio-logical testing programs. Class 100 hoods,clean rooms and isolators are available formicrobial evaluation.

MICROBIOLOGICALTESTING



CONTAINER TESTINGSGS Life Science Services is an industryleader in Container Testing (USP, EP, JP,

BP), providing full packaging testing forthe drug industry. The safety and efcacyof any pharmaceutical product is inextri-cably linked to its packaging. Containersor closures that do not meet the physical,chemical, or biological specications ofthe major compendia will compromise thequality of the drug product.

TESTS INCLUDE

MATERIALS USED FOR THE

MANUFACTURE OF CONTAINERS

■ Identication ■ Limit tests ■ Impurities ■ Assays

CONTAINER TESTING (GLASS,

PLASTICS, RUBBER CLOSURE…)

■ Classication ■ Identication ■ 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



EXTRACTABLES & LEACHABLES TESTINGThe assessment of Extractables andLeachables in bio/pharmaceutical pro-ducts is an important step in drug productdevelopment. Processing equipment, aswell as, primary and secondary containerclosures are potential vectors for chemicalcontaminants.

Monomers and polymer additives suchas antioxidants, plasticisers, stabilizers,dyes, metal catalysts and other harmfulchemicals may potentially migrate into theproduct under storage conditions. SGSprovides a complete service for testingExtractables in container materials and Le-achables in nal products. These tests areconducted in cGMP compliant laboratoriesusing technologies that detect ultra tracelevels.

SERVICES

■ Test strategy planning and dataevaluation based on the availableinformation

■ Development of a tailored study designfor Extractables and Leachables

■ Extractables proling (inorganic andorganic extractables)

■ Sequential extractions and alternativeextraction techniques for isolatingExtractables in container materials

■ Characterization of Extractables bychromatographic and spectroscopicinvestigations

■ Determination of the AnalyticalEstimation Threshold (AET)

■ Calculation of the QualicationThreshold based on Safety ConcernThreshold (SCT)

■ Method development and validation ofpotential Leachables in pharmaceuticalproducts

■ Performing of Leachables studies onpharmaceutical products

■ Reporting and evaluation of resultswithin 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 uorescence analysis ■ ASE (accelerated solvent extraction) ■ Soxhlet



From study design to storage, monitor-ing, analytical testing and documentation,SGS offers services to your completesatisfaction. With more than 20 yearsof experience and currently more than100,000 samples in storage, SGS hasthe skills and the capacity to handle yourstability projects. SGS can provide itscustomers with the complete bandwidthof storage conditions in numerous climaticwalk-in chambers and climatic cabinetswith a total storage capacity of approxi-mately 1,300 m 3. Various refrigerators and

freezers are available for storage at lowertemperatures. All storage chambers arefully controlled with 24h/7d monitoring andalert systems (21 CFR part 11 compliant).For your safety, SGS operates back upchambers for complete sample retrieval.

SERVICES

■ Support in designing studies for realtime, stress tests and photo stabilitystudies

■ Development and validation of “stabilityindicating methods“

■ Examination of stability-relevantparameters

■ Storage and management of stabilitysamples

■ Interim reports for every testing period ■ Comprehensive nal 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-permeablecontainer 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-specic conditions

STABILITY STUDIES



SGS Life Science Services laboratorieshave extensive knowledge and expertisein developing and validating methods forraw materials, API’s, nished products andcleaning validation.

SGS offers development and documenta-tion of analytical protocols and reportsfor proprietary and nonproprietary testmethods and manufacturing processes incompliance with the ICH Q2 (R1) guideline“Validation of Analytical Procedures : Textand Methodology” and FDA guidelines.

Once a method is validated, it may requiretransfer. Method transfer may involvecomparative testing, co-validation betweentwo sites (Lab-to-Lab), complete or partialrevalidation and comprehensive documen-tation (Transfer Plan, Protocol, Report).Whether SGS’ Life Science Services is thedeveloping or the receiving laboratory, wecan assist you with your method transferrequirements.

METHOD DEVELOPMENT

■ Identication ■ 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

■ Specicity ■ Detection limit ■ Quantitation limit ■ Linearity

■ Range ■ Robustness ■ System suitability test

13

METHODDEVELOPMENT & VALIDATION



ENVIRONMENTAL MONITORING

In addition to acceptance tests for theinstallation of clean rooms in productionfacilities, SGS can perform routine moni-toring of viable and nonviable contamina-tion of production facilities.

SGS offers a broad range of monitoringservices for clean rooms and can alsoprovide you with customized hygiene-mon-itoring programs that suit your needs.

SERVICES INCLUDE

■ Viable and nonviable particle counting ofair sample in manufacturing, packagingand testing sites

■ Microbial sampling and enumeration ofsurfaces

■ Cleaning validation studies ■ Disinfectant efcacy studies ■ Microbiological tests on individual pro-cess media (air, water, technical gases)

■ Determination of bacterial count in airunder 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 andprimary packaging

■ Qualication of production facilities afterinstallation, reconstruction, standstill,etc.

■ Conrmation of personal hygiene, de-termination of microbiological exposureon clothing and hands of productionpersonnel



MEDICAL DEVICE TESTING

SGS supports its partners in the medicaldevice industry with a broad range of ser-vices. SGS performs hygienic qualicationof the production facilities, microbiologicaltests on the products before and aftersterilization, and screening for possibleresidual contaminants from the steriliza-tion process (endotoxins, ethylene oxide).SGS also conducts studies for migrationof substances from packaging material

(leachables).

SERVICES INCLUDE

■ Determination of bioburden beforesterilization

■ Sterility testing according to USP andEP of products and biologicalindicators

■ Method development and validation ■ Endotoxin testing

• Gel clot, kinetic, and chromogenic ■ Residual ethylene oxide tesingaccording to EN ISO 10993-7

■ Environmental monitoring ofproduction zones• Viable and nonviable particulate

analysis• RODAC and swab analysis of

surfaces ■ Cytoxicity bioassay ■ Polymer identication

• FTIP, TGA, DSC ■ Container Closure Permeation

• Dye and microbial ingress studies ■ Test for leachable substancesaccording to EN ISO 10993-17

These services are complimented by capa-bilities in other SGS divisions, including CEmark, electrical testing, package integritytesting and Medical Device ISO certica-tion and audits. SGS is the Medical Deviceindutry’s single source provider.



BIOPHARMACEUTICAL SERVICES

SGS MEANS QUALITY

REGULATORY AND QUALITY MANAGEMENT SYSTEMS

*

SGS M-Scan

LABORATORIES COUNTRY QUALITY MANAGEMENTSYSTEMS ISO STANDARD US-FDA

REGISTREREDUS-FDA

INSPECTED

Toronto (Mississauga) Canada GMP/GLP - • •

Chicago (Lincolnshire) USA GMP/GLP 9001 • •

New York (Faireld) USA GMP/GLP 9001 • •

Philadelphia (West Chester) * USA GMP - • •

Brussels (Wavre) Belgium GMP/GLP 17025 • •

Paris (Clichy) France GMP 9001 • •

Poitiers France GLP/GCP - • •

Berlin Germany GMP - • •

Frankfurt (Taunusstein) Germany GMP/GLP 17025 • •

Freiburg* Germany GMP/GLP - • -Geneva* Switzerland GMP/GLP - • •

London (Wokingham)* UK GMP/GLP - • •

Shanghai China GMP 17025 • -Chennai India GMP 17025 • •

Singapore Singapore GMP 17025 • -Taipei Taiwan - 17025 - -Kaohsiung Taiwan - 17025 - -

Preclinical ExploratoryDevelopment

ConfirmatoryDevelopment

Post-Approval RoutineProduction

TradeDistributionSERVICES

L A B O R A T O R Y

S E R V I C E S

B i o p h a r m a c e u t i c a l

Method Development, Optimization & Validation

Amino Acid Sequencing (Edman, MS/MS)

Amino Acid Analysis

Peptide Mapping by MS

Disulfide Analysis

Glycosylation Analysis – Oligosaccharide Population (Glycan profile by MS and LC methods)

Monosaccharide Composition Analysis

Linkage Analysis

Glycosylation Site Determination

Post-Translational Modification Analysis

Isoform and Electrophoretic Patterns

Extinction Coefficient

N- and C-terminal Sequencing

Sialic Acid Analysis

LC Patterns (SEC, RP, IEX)

Spectroscopic Profiles (CD, DSC, NMR)Aggregation Analysis (AUC, SEC-MALS)

Characterization of Process and Product-Related Impurities



CHARACTERIZATIONOFBIOPHARMACEUTICALS

The analysis of biopharmaceuticals suchas recombinant proteins and glycopro-teins, monoclonal antibodies or nucleicacid-based drugs, requires a different skillset than that for small chemical entities.

Many of the analytical techniques such asLC/MS/MS and capillary electrophoresisor quantitative PCR have emerged froman R&D-type setting into routine use forproduct characterization. Nevertheless, thesame demanding quality standards applyfor the quality control of biologicals as forsmall molecule drugs.

With the recent acquisition of M-Scan inNovember 2010, SGS enhances its serviceportfolio for the characterization of biolog-ics with GLP/GMP contract analyticalservices, consultancy and training based

on high-end mass spectrometry, chroma-tography and physicochemical analyses.



CELL LINE

CHARACTERIZATIONSGS uses a variety of nucleic acid andprotein-based technologies to characterizethe identity of cell lines and assess thestructure of the expression construct.According to ICH guideline Q5B, “the char-acterization of the expression constructis … important to ensure the consistentproduction of a recombinant DNA-derivedproduct”. The analysis should “establishthat the correct coding sequence of theproduct is incorporated into the host celland is maintained during culture to theend of production”.

TEST METHODS

■ Gene and plasmid copy number assay■ Flow cytometric analysis (FACS

Canto II) ■ Histocompatibility antigens ■ Southern blotting ■ DNA ngerprinting ■ DNA sequencing

SAFETY TESTING

■ Adventitious virus assay (ICH Q5A) ■ Specic virus/bacteria detection byqPCR

■ Virus titration by plaque assay ■ Haemaglutination / haemadsoptionassay

■ Mycoplasma testing according to Eur.Ph. 2.6.7 and FDA guidelines• Culture method• Indicator cell method• qPCR method

■ Sterility testing• Direct inoculation• Filtration method• Alternative qualied system:

BactT/Alert 3D ■ Bacterial endotoxin testing ■ Detection of Host residualcontaminents:• Residual generic DNA/RNA• Host specic residual DNA• HCP assay



HOST CELL

IMPURITY TESTINGSGS provides you with sufciently sensi-tive test methods to detect host cell impu-rities. Additionally, SGS has the capabilitiesto develop specic host cell protein assaysfor your expression cell line.

Host cell proteins (HCPs) comprise themajor protein contaminants associatedwith biopharmaceuticals derived by recom-binant DNA technology. Protein recovery

processes are required to minimize thecontent of HCPs in the nal product. Hostcell proteins are often immunogenic andcan alter the therapeutic efcacy of a drugor can affect patient safety.

Host cell DNA levels are another cellularcontaminant present in biopharmaceuti-cals. The WHO, the EU and the FDA haveset specic levels of residual host cellDNA that are acceptable in biopharmaceu-tical products.

SGS has the expertise to develop and vali-date specic methods for specic productor 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 ■ Flouresence assays(OliGreen ® and PicoGreen ®)

ANALYSIS OF CELL CULTURE -

DERIVED IMPURITIES

■ Albumin ■ Nutrients



BIOLOGICS SAFETYTESTINGSGS’s Biologics Safety Testing detectscontamination of cell cultures, virus stocksand nal products, with a view to assistingquality control measures in the develop-ment of biopharmaceutical products.

The threat of contamination of cell culturesby adventitious agents such as, endotoxin,viruses, and mycoplasma, should not be

underestimated. For instance, endotoxins,which when present in a nal product,can induce an inammatory response inpatients. Viral contamination can lead tounreliable experiments in biomedical andbiotechnological research and bring aboutsignicant productivity losses in biologi-cal manufacturing. Finally, mycoplasmacan alter virtually every cellular process,including hybridoma selection rates,protein and nucleic acid synthesis, and im-munogenicity and chromosomal damage.Our services therefore test for a range of

contaminants at any stage of drug devel-opment and production.

ENDOTOXIN TEST METHODS

■ LAL gel clot assay ■ LAL photometric assay ■ LAL colorimetric assay

VIRUS TESTING

■ EP 2.6.16 and 5.2.3 and ICH Q5A ■ In vitro adventitious virus assays by

CPE, haemadsorption, and haemagluti-nation assay

■ Virus titration by plaque assay ■ Customer-specic method development

TESTS FOR MYCOPLASMA DETECTION

■ Cell culture method (21 CFR 610.30 andEP 2.6.7)

■ Indicator cell ■ Fluorochrome staining ■ Validated PCR based method with pre-enrichment or direct detection

SAMPLE MATERIALS

■ Biopharmaceutical samples, including:raw materials, intermediate products,API, bulk drugs, and nished products

■ Working and master cell banks ■ Culture media

Conducted by our network of internationalexperts, whose skills and knowledge aresecond to none, our biopharma safetytesting methods are complaint with FDA,USP, EP and ICH guidelines, and also helpyou to ensure that your biopharmaceuticalproducts meet other international and localregulatory requirements.



POTENCY ASSAYSCells-based assays are designed to testthe effectiveness of potential drug candi-dates and measure the effects on indicatorcell lines. Below are some examples ofcell-based potency assays performedby SGS. Since assays will vary depend-ing upon the drug candidate of interest,please consult with your SGS Representa-tive regarding custom-designed assays.

CELL GROWTH ASSAYS

■ Study Design Evaluate the potency of a specic

growth factor ■ Scope of SGS work

SGS develops all protocols anddesigns in vitro bioassay(cell line selection, synchronisedculture, selection endpoints).Provide client with nal report.

■ Measurable assay endpoints:Measure of cell proliferation by MTTassays

INTERLEUKIN PRODUCTION

■ Study Design

Evaluate the potency of an expressionvector (Bacteria) to produce IL-x

■ Scope of SGS work Transfer and Validation of the method Provide client with nal report

■ Measurable assay endpoints: IL-x specic 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 nal report

■ Measurable assay endpoints: Cell Viablility by MTT assay

IDENTIFICATION OF CONTAMINANT CELLS

■ Study Design

Identication and quantitation ofcontaminant cells in a Cell Therapyproduct

■ Scope of SGS work Biomarker identication and Antibody

selection Flow Cytometry set-up Provide client with nal report

■ Measurable assay endpoints: Cell detection and quantitation by FACS



SGS has the necessary expertise andexperience to perform the analysis of yourpeptides, (glyco)proteins, and antibod-ies. A broad portfolio of analytical testmethods ranging from classical gel elec-trophoresis and various chromatographicmethods to the latest mass spectrometrictechniques are available. SGS provides afull analysis package for physicochemicalcharacterization to fulll ICH Q6B require-ments. In addition, the experts at SGSwill help you check for purity and homo-geneity of your protein, identify process-and product-related impurities, analyzepost-translational modications, includingglycosylation patterns, detect aggrega-tion complexes (especially important inantibody formulations), and test for thebiological activity.

TEST METHODS PROTEIN IDENTITY

■ Peptide mass mapping■ Amino acid analysis

■ Disulde bridge assignment ■ Intact protein mass determination ■ Sequence conrmation, including N-andC-terminal (LC/MS/MS)

■ Post-Translational modication 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, uorescence) ■ 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

PROTEIN CHARACTERIZATION



PROTEIN GLYCOSYLATIONANALYSIS

Glycosylation analysis plays an importantrole in establishing the safety and efcacyof nal drug products and, as such, is anessential part of SGS’s analysis portfolio.Highlighting where factors such as cell lineand bioreactor conditions have affectedthe structure, linkage or composition ofglycans within a protein, it is also a keytool in helping to protect your business’sreputation for high-quality products. AtSGS, we have shaped our Protein Gly-cosylation Analysis services to meet therequirements of ICH 6QB, so you can besure you are meeting regulatory expecta-tions.

Our experts are always at hand to giveadvice on what may be most appropriatestrategies for your products, whether youare using glycosylation screening for drugdiscovery (cell line selection) or at anystage of the drug manufacturing process.No matter what your glycoprotein analysisneeds, we offer a commitment to qualityand apply international expertise at a locallevel.

SERVICES

■ Monosaccharide composition analysis:Conrms the presence of carbohydrate(neutral, amino and acidic species) in aproduct

■ Glycan population analysis: Providesa detailed picture of N- and O-linkedglycan structures

■ Glycan antennary proling analysis(including linkage analysis): Informationon structure including multiantennary or

bisected N-glycans ■ Glycosylation site analysis: Glycans atindividual sites on the protein can beisolated and studied

TECHINQUES

■ GC-MS ■ LC-MS ■ MALDI-MS ■ ES-MS

■ HPAEC-PAD ■ HILIC-FLD, HILIC-FLD-MS

Erythroprotein Tamm-Horsfall glycoprotein

Glycodelin S

Glycodelin A



SGS is one of the world’s most trustedexperts for independent biopharmaceuticalanalysis. Clients using our Antibody* Char-acterization Services benet from our vastexperience gained from analyzing hun-dreds of biotechnology products. Whetheryou need antibody analysis to support drugdiscovery or the drug manufacturing pro-cess, we offer tailor-made solutions basedon your particular business requirements.Our services can be an individual analysisor a comprehensive package. SGS’s anti-body sequencing and analysis is carriedout to the high standards demanded byour global quality assurance network andthe requirements of FDA, EMA and ICHguidelines. Contact us today to discusshow you can draw on our internationalexpertise for your antibody analysis needsto help reduce time to market.

SERVICES

■ Amino acid sequence analysis (Edmanand MS/MS)

■ Amino acid composition analysis anddetermination of extinction coefcient

■ N-terminal and C-terminal amino acidsequencing

■ Peptide mass mapping ■ Disulde bridge analysis assignment ■ A range of carbohydrate structure

analyses including:• monosaccharide composition• oligosaccharide proling• linkage analysis• glycosylation site determination

■ Determination of intact molecularweight

■ Electrophoretic and isoform patterns ■ Liquid chromatographic patterns ■ Identication of post-translational modi-cations

■ Spectroscopic proling (CD, NMR) ■ Identication of degradation-relatedproduct impurities including:• Deamidation• Oxidation

■ Protein aggregation assessment (AUC,SEC/MALS, DSC)

■ Immuno and cell-based assays

ANTIBODY*

PRODUCT ANALYSIS

* Antibody and Antibody-related (e.g. fragments)



BIOANALYSISWith over 20 years of experience, and its

two GLP certied and FDA inspected labs,SGS has an international reputation forcomplex method development and valida-tion as well as for the analysis of drugs inbiological uids. SGS has the expertise toboth develop assays from scratch (includ-ing immunoassays) and to support largescale sample analyses, from pre-clinicaland clinical studies.

To support the bioanalysis of variousclasses of compounds, SGS offers over600 validated techniques and methods.(visit http://www.sgs.com/ba-methods)Exceptional sample processing and analyti-cal capabilities, combined with scienticexpertise, enable SGS to provide clientswith rapid high-volume bioanalysis:

SERVICES

■ In vitro models (cell-based bioassays) ■ ADME ( 14C-based analysis) ■ Pre-clinical development ■ Early to late phase clinical trials ■ Biomarkers ■ Immunogenicity testing and analysis ofbiological products

■ Marketed drugs (interactions &reformulations)

TESTING METHODS

■ High throughput mass spectrometry: 31LC/MS/MS, including UPLC with a PDAdetector; dried blood spot preparationcapabilities

■ Automated sample preparation usingrobotics (Multiprobe) and turbulent owtechnology

■ Complete Immunogenicity testing• Screening, conrmatory, characteriza-

tion and neutralizing antibody assays• ELISA, RIA, ECL, cell-based assay,

ow cytometry• Quantication of therapeutic biologi-

cals and associated biomarkers forPK/TK studies



SGS MEANSPROXIMITY

AMERICAS

CANADA • Toronto (Mississauga, ON)

USA

• Chicago (Lincolnshire, IL) • New York (Faireld, 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

SINGAPORE

• Singapore

TAIWAN

• Kaohsiung • Taipei

VISIT SGS.COM/PHARMAQC



EUROPEBELGIUM (WAVRE)

+32 10 42 11 [email protected]

FRANCE (CLICHY)+33 1 41 06 95 [email protected]

FRANCE (POITIERS)

+33 5 49 57 04 [email protected]

GERMANY (BERLIN)

+49 30 3460 [email protected]

GERMANY (FREIBURG)

+49 761 6116 7760

[email protected]

GERMANY (TAUNUSSTEIN)


SWITZERLAND (GENEVA)

+41 22 794 83 [email protected]

UK (WOKINGHAM)

+44 1189 [email protected]

ASIA

INDIA (CHENNAI)


SINGAPORE (SINGAPORE)+65 63790 [email protected]

CHINA (SHANGHAI)


TAIWAN (TAIPEI / KAOHSIUNG)

+886 2 2299 3279 ext [email protected]

NORTH AMERICA

CANADA (MISSISSAUGA)

+ 1 905 364 [email protected]

USA (FAIRFIELD, NJ)


USA (LINCOLNSHIRE, IL)


USA (WEST CHESTER, PA)


SGS LIFE SCIENCE SERVICE LOCATIONS

CONTACT US



WWW.SGS.COM

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SGS LSS Lab Services Brochure en 11

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