Mobile Affinity Selection Chromatography Analysis of Therapeutic Monoclonal Antibodies.

ABSTRACT: Federal regulatory agencies require continuous verification of recombinant therapeutic monoclonal antibody (mAb) quality that is commonly achieved in a two-step process. First, the host-cell proteome and metabolome are removed from the production medium by protein A affinity chromatography. Second, following recovery from the affinity column with an acidic wash, mAb quality is assessed in multiple ways by liquid chromatography-mass spectrometry (LC-MS). However, lengthy sample preparation and the lack of higher-order structure analyses are limitations of this approach. To address these issues, this report presents an integrated approach for the analysis of two critical quality attributes of mAbs, namely titer and relative aggregate content. Integration of sample preparation and molecular-r

SUBMITTER: Narsimhan ML 

PROVIDER: S-EPMC10633814 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature