Post on 23-Jul-2020
Antibody products should be characterized according to ICH, EMA and FDA guidelines. SGS M-Scan provides a full GLP/cGMP analysis package for product characterization and identification of post translational modifications, which include:
Structural characterization and confirmation:
Amino acid sequence
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 HPAEC-PAD, HILIC-FLD and MS Linkage analysis Glycosylation site analysis
Deamidation
Oxidation
ANTIBODY PRODUCT ANALYSISIN ACCORDANCE WITH REGULATORY GUIDELINES
Physicochemical properties
Molecular weight or size Gel electrophoresis MALDI-TOF or ES-Q-TOF-MS
Isoform pattern
Extinction coefficient
Electrophoretic pattern
Imaging cIEF
Liquid Chromatographic patterns
Reverse Phase
Size Exclusion
Ion-Exchange profiling
Spectroscopic profiles
UV/Vis
Circular Dichroism
NMR
Aggregation
Analytical Ultracentrifugation (AUC)
SEC-MALS
Differential Scanning Calorimetry (DSC)
SGS M-Scan is now part of SGS Life Science Services, the largest network of contract testing laboratories. With 25 facilities across 14 countries, SGS Life Science Services is a leading contract service organization providing clinical research services, analytical development, biologics characterization, and quality control testing.
CONTACT INFORMATION
EUROPE
BELGIUM (WAVRE)+32 10 42 11 11be.pharmaqc@sgs.com
FRANCE (POITIERS)+33 (0) 5 49 57 04 04clinicalresearch@sgs.com
GERMANY (FREIBURG)+49 761 6116 7760de.m-scan@sgs.com
GERMANY (TAUNUSSTEIN)+49 6128 744 245de.pharmaqc@sgs.com
SWITZERLAND (GENEVA)+41 22 794 8374ch.m-scan@sgs.com
UK (WOKINGHAM)+44 (0) 1189 896940uk.m-scan@sgs.com
BIOPHARMACEUTICAL LABORATORY SITES AND CONTACTS
NORTH AMERICA
CANADA (MISSISSAUGA)+ 1 905 364 3757ca.pharmaqc@sgs.com
USA (WEST CHESTER, PA)+ 1 610 696 8210us.m-scan@sgs.com
ASIA+65 637 90 111pharmaqc@sgs.com
M-SCAN IS NOW PART OF SGS IS THE WORLD’S LEADING INSPECTION, VERIFICATION, TESTING AND CERTIFICATION COMPANY
WWW.SGS.COM/M-SCAN © S
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