Antibody Characterization

of polyclonal and recombinant monoclonal antibodies

Our protein contract services can be applied in early discovery and throughout manufacturing and clinical development of polyclonal and monoclonal antibody-based pharmaceuticals. The analysis reports may be used for regulatory purposes as described in the ICH Guidelines Q6B, and Guideline on Development, Production, Characterisation and Specifications for Monoclonal Antibodies and Related Products.

Antibody analyses:

• Heavy and light chain Mw determination by mass spectrometry
• Peptide mapping by mass spectrometry of heavy and light chain
• N- and C-terminal sequencing of heavy and light chain by MALDI ISD
• Edman N-terminal sequencing
• CDR sequencing of variable complementary determining regions
• 1D SDS PAGE and 2D PAGE electrophoresis
• Post translational modification analysis; deamidation, oxidation, pyroglutamate, N-glycosylation
• Antibody quantification assay by LC MS/MS
• Host Cell Protein (HCP) identification