Assessing the immunogenicity risk of salmon calcitonin peptide impurities using in silico and in vitro methods.

ABSTRACT: Advances in synthetic peptide synthesis have enabled rapid and cost-effective peptide drug manufacturing. For this reason, peptide drugs that were first produced using recombinant DNA (rDNA) technology are now being produced using solid- and liquid-phase peptide synthesis. While peptide synthesis has some advantages over rDNA expression methods, new peptide-related impurities that differ from the active pharmaceutical ingredient (API) may be generated during synthesis. These impurity byproducts of the original peptide sequence feature amino acid insertions, deletions, and side-chain modifications that may alter the immunogenicity risk profile of the drug product. Impurities resulting from synthesis have become the special focus of regulatory review and approval for human use, as outlined i

SUBMITTER: Roberts BJ 

PROVIDER: S-EPMC11341359 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature