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Laboratory Services AT

SGS LIFE SCIENCE SERVICES

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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. shareholders and patients worldwide. With a strong focus on biologics. the Life Science industry finds its inspiration in nature for past and future discoveries. biologics characterization and quality control testing of pharmaceuticals. 3 . In our industry’s constantly evolving world of science and regulation. employees. analytical development. biopharmaceuticals and medical devices – thereby creating value for our clients.LIFE INSPIRED CREATIVE SOLUTIONS IN BIOPHARMACEUTICAL CHARACTERIZATION. SGS Life Science Services’ mission is to safeguard the quality of medicines by providing professional and independent services in clinical research. finding creative solutions is mandatory for success. ANALYTICAL DEVELOPMENT AND QUALITY CONTROL TESTING Just as LIFE derives its source from nature’s flora and fauna.

state-of-theart clinical pharmacology units and the world’s largest network of GMP compliant laboratories.A TRULY GLOBAL NETWORK With 1. The following pages outline the services we perform within our global network and offer to our clients in order to facilitate R&D.300 employees. SGS serves the pharmaceutical. biotechnology and medical device industries across Europe. SGS’s mission is to safeguard the quality of medicines by providing professional and independent services. the Americas and Asia with 25 facilities located in 14 countries. analytical development and quality control release of medicines and medicinal products. .

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

LABORATORY SERVICES SERVICES Preclinical Preclinical Exploratory Exploratory Development Confirmatory Development Post-Approval Post-Approval Routine Routine Production Trade Distribution R&D/Quality Control GMP Analytical Chemistry – QC Release Microbiological Testing Extractables & Leachables – Container Testing Stability Studies (ICH) & Storage Environmental Monitoring (incl. Optimization & Validation 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 Bioanalysis – PK/PD Mass Spectrometry – Large & Small Molecules ADME-14C Trials Flow Cytometry SERVICES WITHIN OUR NETWORK LABORATORY CAPABILITIES Laboratories Country 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 Singapore Singapore Kaohsiung Taiwan Taipei Taiwan * SGS M-Scan Analytical Chemistry Microbiology Stability Studies Method Dev. Utilities Analysis – Gaz & Water) Biologics Safety Testing – Endotoxin. Virus. Mycoplasma Bioanalytical Biopharmaceutical LABORATORY SERVICES Method Development. & Validation Container Testing Medical Device • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • - • • • • • • • • • • • • • • • - • • • • • • • • • • - • • • • • • • • • - Biopharma Bioanalysis Testing • • • • • • • - • • • - .

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

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

Capabilities range from assessment of microbial contamination to confirmation of antimicrobial activity. providing a complete array of services for the bio/pharmaceutical industry. SGS’ scientists are published and active on the scientific committees of several organizations. clean rooms and isolators are available for microbial evaluation. SGS’ facilities meet the demanding cleanliness and engineering requirements of microbiological testing programs. condoms.MICROBIOLOGICAL TESTING SGS is a leader in Microbiology Quality Control testing. etc. Class 100 hoods. personal care products. medical gloves.) ■■Particulate testing ■■Closure integrity testing . hygienic and antibacterial test: contact lenses. 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.

PLASTICS. ■■Leachables ■■Extractables studies ■■Migration studies ■■Others 10 . ■■23°C / 75% r. 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. Containers or closures that do not meet the physical.h.CONTAINER TESTING SGS Life Science Services is an industry leader in Container Testing (USP. The safety and efficacy of any pharmaceutical product is inextricably linked to its packaging. BP). chemical. or biological specifications of the major compendia will compromise the quality of the drug product. providing full packaging testing for the drug industry. EP. TESTS INCLUDE MATERIALS USED FOR THE MANUFACTURE OF CONTAINERS ■■Identification ■■Limit tests ■■Impurities ■■Assays CONTAINER TESTING (GLASS. JP.

stabilizers. Processing equipment. ECD. DCS ■■X-ray fluorescence analysis ■■ASE (accelerated solvent extraction) ■■Soxhlet . Monomers and polymer additives such as antioxidants. GC-MS ■■GC-TEA (nitrosamines) ■■ICP-OES. ICP-MS. as well as. 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. SGS provides a complete service for testing Extractables in container materials and Leachables in final products. plasticisers. HPLC Q-Tof. HS-GC-MS ■■GC (FID. These tests are conducted in cGMP compliant laboratories using technologies that detect ultra trace levels. HPLC-UV. DAD ■■HS-GC. primary and secondary container closures are potential vectors for chemical contaminants. FID-NP). dyes.EXTRACTABLES & LEACHABLES TESTING The assessment of Extractables and Leachables in bio/pharmaceutical products is an important step in drug product development. IR ■■FTIR ■■TGA. AAS. metal catalysts and other harmful chemicals may potentially migrate into the product under storage conditions.

h.h. 25°C / 60% r. ■■+5°C ■■–20°C ■■–80°C ■■Photostability ■■Transport stability (freeze and thaw. and / or 30°C/75% r. IV. All storage chambers are fully controlled with 24h/7d monitoring and alert systems (21 CFR part 11 compliant). 21°C / 45% r. With more than 20 years of experience and currently more than 100. INTERMEDIATE AND ACCELERATED STORAGE ■■25°C / 40% r. 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. III. SGS offers services to your complete satisfaction.h. SGS has the skills and the capacity to handle your stability projects.h.h. (semi-permeable container study) ■■25°C / 60% r. 30°C / 35% r. 30°C / 65% r. SERVICES ■■Support in designing studies for real time.h.h.h.h. For your safety. 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.000 samples in storage. SGS operates back up chambers for complete sample retrieval. LONG-TERM.300 m3. ■■40°C / not more than (NMT) 25% r. ■■30°C / 65% r.h.h.h. monitoring.STABILITY STUDIES From study design to storage. ■■30°C / 75% r. Various refrigerators and freezers are available for storage at lower temperatures. ■■30°C / 70% r. II. analytical testing and documentation. ■■40°C / 75% r. cycle test) ■■In-use stability ■■Customer-specific conditions .

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. Protocol. Once a method is validated.Method Development & Validation SGS Life Science Services laboratories have extensive knowledge and expertise in developing and validating methods for raw materials. we can assist you with your method transfer requirements. co-validation between two sites (Lab-to-Lab). finished products and cleaning validation. Whether SGS’ Life Science Services is the developing or the receiving laboratory. complete or partial revalidation and comprehensive documentation (Transfer Plan. it may require transfer. Report). 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 . Method transfer may involve comparative testing. API’s.

g. packaging and testing sites ■■Microbial sampling and enumeration of surfaces ■■Cleaning validation studies ■■Disinfectant efficacy studies ■■Microbiological tests on individual process media (air. consumables and primary packaging ■■Qualification of production facilities after installation. SERVICES INCLUDE ■■Viable and nonviable particle counting of air sample in manufacturing. particle. determination of microbiological exposure on clothing and hands of production personnel . oil and organic residues in gases) ■■Testing surfaces. ■■Confirmation of personal hygiene. reconstruction.ENVIRONMENTAL MONITORING In addition to acceptance tests for the installation of clean rooms in production facilities. standstill. humidity. technical gases) ■■Determination of bacterial count in air under all operating conditions ■■Particle measurement ■■Determination of TOC (total organic carbon) ■■Media Control (e. SGS can perform routine monitoring of viable and nonviable contamination of production facilities. water. etc. 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.

including CE mark. TGA. package integrity testing and Medical Device ISO certification and audits. SGS also conducts studies for migration of substances from packaging material (leachables). kinetic. microbiological tests on the products before and after sterilization. and chromogenic ■■Residual ethylene oxide tesing according to EN ISO 10993-7 ■■Environmental monitoring of production zones • Viable and nonviable particulate analysis • RODAC and swab analysis of surfaces ■■Cytoxicity bioassay ■■Polymer identification • FTIP. . and screening for possible residual contaminants from the sterilization process (endotoxins. DSC ■■Container Closure Permeation • Dye and microbial ingress studies ■■Test for leachable substances according to EN ISO 10993-17 These services are complimented by capabilities in other SGS divisions. electrical testing. SGS performs hygienic qualification of the production facilities. ethylene oxide). 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.MEDICAL DEVICE TESTING SGS supports its partners in the medical device industry with a broad range of services. SGS is the Medical Device indutry’s single source provider.

Optimization & Validation Amino Acid Sequencing (Edman. RP. NMR) Aggregation Analysis (AUC. IEX) Spectroscopic Profiles (CD. DSC.and C-terminal Sequencing Biopharmaceutical LABORATORY SERVICES Peptide Mapping by MS 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.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 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 SGS M-Scan SGS MEANS QUALITY BIOPHARMACEUTICAL SERVICES SERVICES Preclinical Exploratory Development Confirmatory Development Post-Approval Routine Production Method Development. SEC-MALS) Characterization of Process and Product-Related Impurities Trade Distribution . MS/MS) Amino Acid Analysis N.

consultancy and training based on high-end mass spectrometry. 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. 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. monoclonal antibodies or nucleic acid-based drugs. chromatography and physicochemical analyses. SGS enhances its service portfolio for the characterization of biologics with GLP/GMP contract analytical services.CHARACTERIZATION of BIOpharmaceuticaLs The analysis of biopharmaceuticals such as recombinant proteins and glycoproteins. requires a different skill set than that for small chemical entities. .

2. Ph. According to ICH guideline Q5B.7 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 . “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”.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.6. 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.

HOST CELL IMPURITY TESTING SGS provides you with sufficiently sensitive test methods to detect host cell impurities. SGS has the capabilities to develop specific host cell protein assays for your expression cell line. SGS has the expertise to develop and validate specific methods for specific product or purpose. Protein recovery processes are required to minimize the content of HCPs in the final product. 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 . Additionally. 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. Host cell proteins (HCPs) comprise the major protein contaminants associated with biopharmaceuticals derived by recombinant DNA technology.

and also help you to ensure that your biopharmaceutical products meet other international and local regulatory requirements. protein and nucleic acid synthesis. EP and ICH guidelines. our biopharma safety testing methods are complaint with FDA.3 and ICH Q5A ■■In vitro adventitious virus assays by CPE. API. Viral contamination can lead to unreliable experiments in biomedical and biotechnological research and bring about significant productivity losses in biological manufacturing. haemadsorption. and mycoplasma. including hybridoma selection rates. USP. viruses. and finished products ■■Working and master cell banks ■■Culture media Conducted by our network of international experts.6. and immunogenicity and chromosomal damage.6. endotoxins. The threat of contamination of cell cultures by adventitious agents such as. Endotoxin test methods ■■LAL gel clot assay ■■LAL photometric assay ■■LAL colorimetric assay Virus testing ■■EP 2. bulk drugs. For instance. including: raw materials. endotoxin. can induce an inflammatory response in patients. intermediate products. Our services therefore test for a range of contaminants at any stage of drug development and production. with a view to assisting quality control measures in the development of biopharmaceutical products.30 and EP 2. Finally. should not be underestimated. which when present in a final product. and haemaglutination assay ■■Virus titration by plaque assay ■■Customer-specific method development Tests for mycoplasma detection ■■Cell culture method (21 CFR 610. virus stocks and final products.16 and 5.2. mycoplasma can alter virtually every cellular process. .7) ■■Indicator cell ■■Fluorochrome staining ■■Validated PCR based method with preenrichment or direct detection Sample Materials ■■Biopharmaceutical samples. whose skills and knowledge are second to none.BIOLOGICS SAFETY TESTING SGS’s Biologics Safety Testing detects contamination of cell cultures.

synchronised culture. please consult with your SGS Representative regarding custom-designed assays. selection endpoints). Since assays will vary depending upon the drug candidate of interest. Provide client with final report. INTERLEUKIN PRODUCTION IDENTIFICATION OF CONTAMINANT CELLS ■■Study Design ■■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 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 CELL GROWTH ASSAYS ■■Study Design VIRAL INHIBITION BY IFNs Evaluate the potency of a specific growth factor ■■Scope of SGS work SGS develops all protocols and designs in vitro bioassay (cell line selection. Below are some examples of cell-based potency assays performed by SGS.POTENCY ASSAYS Cells-based assays are designed to test the effectiveness of potential drug candidates and measure the effects on indicator cell lines. ■■Measurable assay endpoints: Measure of cell proliferation by MTT assays ■■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 .

detect aggregation complexes (especially important in antibody formulations). ELSD. glycerol) ■■Protein concentration . SEC/MALS. non-reduced) ■■cIEF ■■N-terminal sequencing (Edman) ■■Variants analysis (LC/MS/MS) ■■Degradation products/stability (LC/MS/ MS. etc. including glycosylation patterns. the experts at SGS will help you check for purity and homogeneity of your protein. including N-and C-terminal (LC/MS/MS) ■■Post-Translational modification analysis (phosphorylation. di-.PROTEIN CHARACTERIZATION SGS has the necessary expertise and experience to perform the analysis of your peptides. In addition. UV. (glyco)proteins. identify processand product-related impurities. TEST METHODS PROTEIN IDENTITY ■■Peptide mass mapping ■■Amino acid analysis ■■Disulfide bridge assignment ■■Intact protein mass determination ■■Sequence confirmation. CD) PROTEIN/ ANTIBODY AGGREGATION ANALYSIS ■■HPLC-SEC. 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. RI. and test for the biological activity. analyze post-translational modifications. and MS ■■Analytical ultracentrifugation (AUC) ■■SDS-PAGE BIOLOGICAL ACTIVITY ■■ELISA ■■Bioassays ■■Detection of glycerides (tri-.) ■■Methionine oxidation status ■■Antibody typing and subclass analysis ■■PEGylation status ■■Isoform and electrophoretic patterns ■■Western blotting PROTEIN PURITY ■■RP-HPLC (UV. mono-. and antibodies. fluorescence) ■■IE-HPLC ■■SEC-HPLC ■■SDS-PAGE (reduced. DSC.

At SGS. whether you are using glycosylation screening for drug discovery (cell line selection) or at any stage of the drug manufacturing process. SERVICES ■■Monosaccharide composition analysis: Confirms the presence of carbohydrate (neutral. Highlighting where factors such as cell line and bioreactor conditions have affected the structure. No matter what your glycoprotein analysis needs. we have shaped our Protein Glycosylation Analysis services to meet the requirements of ICH 6QB.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.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. amino and acidic species) in a product ■■Glycan population analysis: Provides a detailed picture of N. as such. HILIC-FLD-MS . is an essential part of SGS’s analysis portfolio. we offer a commitment to quality and apply international expertise at a local level. it is also a key tool in helping to protect your business’s reputation for high-quality products. linkage or composition of glycans within a protein. 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 need antibody analysis to support drug discovery or the drug manufacturing process. we offer tailor-made solutions based on your particular business requirements. EMA and ICH guidelines.ANTIBODY* PRODUCT ANALYSIS SGS is one of the world’s most trusted experts for independent biopharmaceutical analysis. DSC) ■■Immuno and cell-based assays * Antibody and Antibody-related (e. NMR) ■■Identification of degradation-related product impurities including: • Deamidation • Oxidation ■■Protein aggregation assessment (AUC. 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. Our services can be an individual analysis or a comprehensive package.g. 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. Clients using our Antibody* Characterization Services benefit from our vast experience gained from analyzing hundreds of biotechnology products. SEC/MALS. fragments) . Contact us today to discuss how you can draw on our international expertise for your antibody analysis needs to help reduce time to market.

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

ON) Belgium • Brussels (Wavre) China • Shanghai USA • Chicago (Lincolnshire.SGS MEANS PROXIMITY AMERICAS EUROPE ASIA Canada • Toronto (Mississauga. NJ) • Philadelphia (West Chester. PA) France • Paris (Clichy) • Poitiers India • Chennai Germany • Berlin • Frankfurt (Taunusstein) • Freiburg Switzerland • Geneva United Kingdom • London (Wokingham) VISIT SGS.com/PHARMAQC Singapore • Singapore Taiwan • Kaohsiung • Taipei . IL) • New York (Fairfield.

com ASIA INDIA (CHENNAI) +91 44 6462 9711 in.pharmaqc@sgs.pharmaqc@sgs.com NORTH AMERICA CANADA (Mississauga) + 1 905 364 3757 ca. IL) +1 847 821 8900 us.pharmaqc@sgs.com USA (WEST CHESTER.com UK (wokingham) +44 1189 896940 uk. PA) + 1 610 696 8210 us.m-scan@sgs.com Germany (Freiburg) +49 761 6116 7760 de.pharmaqc@sgs.pharmaqc@sgs.com USA (Fairfield.pharmaqc@sgs.com USA (LINCOLNSHIRE.pharmaqc@sgs.m-scan@sgs.com TAIWAN (TAIPEI / KAOHSIUNG) +886 2 2299 3279 ext 2500 tw.m-scan@sgs.com SINGAPORE (SINGAPORE) +65 63790 111 sg.com CHINA (SHANGHAI) +86 21 6115 2197 cn.com Switzerland (Geneva) +41 22 794 83 74 ch.pharmaqc@sgs.CONTACT US SGS LIFE SCIENCE SERVICE LOCATIONS EUROPE BELGIUM (Wavre) +32 10 42 11 11 be.com FRANCE (CLICHY) +33 1 41 06 95 93 fr.pharmaqc@sgs.pharmaqc@sgs.com GERMANY (BERLIN) +49 30 3460 7500 de.com GERMANY (Taunusstein) +49 6128 744 245 de. NJ) + 1 888 747 8782 us.com .m-scan@sgs.pharmaqc@sgs.com FRANCE (POITIERS) +33 5 49 57 04 04 clinicalresearch@sgs.

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