Pharmaceuticals have historically been small molecules. Today however, many newly approved drugs are derived from proteins. For protein therapeutics to be effective, they must be produced in biologically active forms, which require proper folding, and post-translation modifications (PTMs). Detailed characterization of these modifications is crucial. A comprehensive verification
of the protein’s (amino acid) sequence, assessment and identification of impurities in a recombinant protein drug product along with a detailed characterization of the existing PTMs, is a regulatory requirement prior to its approval for clinical use.
United States
