peptide mapping
Peptide mapping, the principal technique for confirming a proteinu2019s primary structure (amino acid sequence), can be used in drug discovery and throughout the manufacturing process. It is one of the most important techniques in comparability studies of biologics and a key step in the characterization of biopharmaceutical proteins. For recombinant protein drugs, such as monoclonal antibodies (mAbs) and antibody drug conjugates (ADCs), peptide mapping can be used for identification, primary structural characterization, and quality assurance/quality control (QA/QC). Some global regulators, like the US Food and Drug Administration (US FDA) and the European Medicines Agency (EMA), have developed guidelines to ask for providing peptide mapping to confirm the amino acid sequence of drug substance proteins.
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