Mass Spectrometric Conjugate CharacterizationProcess Qualification of Recombinant Protein-Hapten Conjugation

摘要

Conjugated protein biotherapeutics such as PEGylated proteins (with polyethylene glycol), antibody-drug conjugates (ADCs), and protein-haptens often present unique analytical challenges related to characterizing the conjugation aspect of their manufacturing processes. Analytical characterization of this class of proteins requires knowledge of the sites of conjugation, the degree of conjugation, and the drug-to-protein ratio.Here we present case studies in development of reliable methods based on mass spectrometry (MS) to characterize a protein-hapten drug substance during late-phase process validation. This protein is modified by succinylation to enable conjugation with anaminated hapten.