J Pharm Biomed Anal 2021 Jul 7;204:114251. Epub 2021 Jul 7.
CMC Analytical, GlaxoSmithKline, 1250 S. Collegeville Road, UP 1400, Collegeville, PA, 19426, USA.
The identification and control of monoclonal antibody (mAb) critical quality attributes (CQAs) is a key component of quality by design (QbD). In this work, rapid peptide mapping and native intact charge variants analysis have been developed to comprehensively characterize and monitor mAb CQAs using a microfluidic capillary electrophoresis - mass spectrometry (CE-MS) platform. The ultrafast peptide mapping simultaneously analyzed multiple CQAs, including protein primary structure, oxidation, deamidation, succinimide, C-terminal lysine (Lys) clipping, N-terminal cyclization, and glycosylation. Read More