Development of Peptide Mapping
Method for Biopharmaceutical Clients
Peptide mapping is a component of the analytical technologies used within the biopharmaceutical industry to aid in the identity confirmation of a protein therapeutic and to monitor degradative events such as oxidation, glycosylation or deamidation. Accurately identifying the post-translational modifications, such as protein glycosylation, is important as part of global regulatory guidelines as they play several crucial roles in the function of biotherapeutics.
The application of peptide mapping includes amino acid structure of proteins. For recombinant protein pharmaceuticals, such as monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs), peptide mapping is used for proof of identity, primary structural characterization, quality control (QC) and quality assurance (QA).
To continue reading, please fill out the form.