Improved process intermediate stability through the identification and elimination of reactive glycation residues - a monoclonal antibody case study.

ABSTRACT: The manufacturing of therapeutic biologics can result in a heterogeneous population of charge variants, encompassing many quality attributes which could impact activity and pharmacokinetics. Monitoring the relative abundance of these charge variants to demonstrate process consistency is an expectation of regulatory agencies. Control of the relative abundance of charge variants is also necessary to ensure product comparability across the product lifecycle. We have observed a significant shift in the relative abundance of charged species, as measured by capillary isoelectric focusing, during clarified cell culture fluid holds for several monoclonal antibodies. This lack of stability requires that the hold time for this process intermediate be significantly curtailed, eliminating manufacturin

SUBMITTER: Bosley A 

PROVIDER: S-EPMC9342189 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature