Antibodies are unique proteins with many interesting properties. They can be used both as a tool in the lab and as new drugs. Alphalyse’s Protein Analytical Methods can provide you with important and detailed information about polyclonal and monoclonal antibodies and help throughout the development phase. The methods also provide information for regulatory purposes as described in the ICH Guidelines Q6B, and Guideline on Development, Production, Characterisation and Specifications for Monoclonal Antibodies and Related Products.

Alphalyse can provide you with a detailed characterization of your antibody including:

• Intact mass determination by mass spectrometry of heavy and light chain
• Peptide mapping by mass spectrometry of heavy and light chain
• N- and C-terminal sequencing of heavy and light chain by Edman degradation and MALDI ISD MS
• De-novo sequencing of variable complementary determining regions (CDR)
• HPLC, SDS PAGE, IEF analysis
• Post translational modification analysis; deamidation, oxidation, N-terminal pyroglutamate
• N-glycosylation site characterization
• Free sulphydryl (thiol) groups and disulfide bridge determination
• Assay for absolute protein quantification
• Assay for Host Cell Protein (HCP) identification

Please contact us to discuss your specific project in more detail.  We will provide you with a full project proposal within 2 days that includes analysis protocols, timelines and costs.