Therapeutic monoclonal antibodies play an important role in biopharmaceuticals, and gradually become one of the main directions of the development of biological medicine. The quality control of monoclonal antibodies has also become the focus of global biopharma companies and regulatory agencies. Capillary electrophoresis has become an important tool in the analysis of monoclonal antibodies with multi-modes and high resolution. In this paper, we reviewed the application of capillary gel electrophoresis, capillary isoelectric focusing and capillary zone electrophoresis on the analysis of purity, isoelectric point/charge heterogeneity and N-glycan profiling of therapeutic monoclonal antibodies.
Keywords: N-glycan; capillary electrophoresis (CE); capillary gel electrophoresis (CGE); capillary isoelectric focusing (CIEF); capillary zone electrophoresis (CZE); charge heterogeneity; purity; review; therapeutic monoclonal antibody (mAb).