Analysis of Monoclonal Antibodies by Capillary Electrophoresis: Sample Preparation, Separation, and Detection

Therapeutic monoclonal antibodies (mAbs) are dominating the biopharmaceutical field due to fact of their high specificity in treatment diverse diseases. Nevertheless, mAbs very complex glycoproteins exhibiting several macro- and microheterogeneities that may affect safety, quality, efficacy. This complexity is challenging for development, formulation, quality control. To tackle issue, a combination multiple analytical approaches necessary. In this perspective, capillary electrophoresis has gained considerable interest over last decade its complementary features chromatographic approaches. review provides an overview strategies derivatives analysis by hyphenated ultraviolet, fluorescence, mass spectrometry detection. The main sample preparation used mAb characterization (i.e., intact, middle-up/down, bottom-up) detailed. different electrophoretic modes as well integrated (sample separation) critically discussed.