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SGS Life Science Services is a leading contract service organization providing clinical research, pharmaceutical development, biologics characterization, biosafety, and quality control testing. Operating 20 laboratories in 11 countries, SGS represents the broadest, wholly-owned, global network of contract analytical laboratories. SGS delivers solutions for pharmaceutical, biologics, and medical-device manufacturers, SGS provides clinical trial management (Phase I to IV) and services encompassing, data management, biostatistics, and regulatory consultancy. SGS also offers GMP/GLP contract laboratory services that include:
  • Quality Control testing of raw materials, APIs, and finished products
  • Monograph testing (USP, EP, BP, and JP)
  • Analytical method development and validation
  • Antibody product analysis
  • Bioanalysis, mass spectrometry and immunoassays
  • Biologics safety testing (endotoxin, virus and mycoplasma)
  • Cell-line characterization
  • Comparative Dissolution Profiling
  • Container testing (extractables and leachables)
  • Environmental Monitoring
  • Glycosylation Analysis
  • Host-cell impurity testing
  • Medical-device testing
  • Microbiological testing
  • Protein/peptide analysis and quantification
  • Stability testing according to ICH/ASEAN guidelines or customer specifications     
  • Water System validation

Technical Information:


Large Molecules
Structural Characterization and Confirmation (ICH Q6B)
  • Protein and Peptide Sequencing (confirmation and de novo sequencing)
  • Amino acid composition
  • N- and C- terminal sequence
  • N-terminal sequencing (automated Edman)
  • MS/MS peptide sequencing
  • Peptide map
  • Sulphydryl groups and disulphide bridges
Carbohydrate structure
  • Monosaccharide composition analysis
  • Sialic acid analysis
  • Oligosaccharide profiling by MS, HPAEC-PAD, HILIC-FLD/MS, CE-LIF
  • Linkage analysis
  • Glycosylation site analysis
Post Translational modification analyses (qualitative and quantitative)
Physicochemical Properties
  • Molecular weight or size
  • Isoform pattern
  • Extinction coefficient
  • Liquid Chromatographic Patterns
  • Gel and Capillary Electrophoretic patterns
Spectroscopic profiles
  • UV/Vis
  • Circular Dichroism
  • FTIR
Aggregation
  • Analytical Ultracentrifugation (AUC)
  • SEC-MALS
  • DLS
Process- and Product-related Impurities - qualitative and quantitative
HCP by LC - MS/MS
Unknown Identification
Oligonucleotide characterization by Mass Spectrometry

Small Molecules
Characterization
Quantitative Mass Spectrometry

Process- and Product- related Impurities - qualitative and quantitative analyses
Unknown Identification

General Procedures (ICH and USP)
R&D Projects
Method Development
Method Transfer, Qualification and Validation
Release Testing
Solid particle characterization
Process and/or product troubleshooting
Glass vial delamination studies

Contact

610-696-8210

 Company Website

606 Brandywine Parkway

West Chester, PA 19380 US

DISCLAIMER: This Laboratory Profile was provided by the company above.