Insights from capillary electrophoresis approaches for characterization of monoclonal antibodies and antibody drug conjugates in the period 2016–2018

Monoclonal antibodies (mAbs) and their related products as antibody-drug-conjugates (ADCs) or biosimi-lars represent a constantly growing class of molecules therapeutic proteins used as treatment against nu-merous diseases. These compounds can undergo several modifications which could alter the efficiency of treatments. In this context, several analytical methods were designed to deliver a comprehensive struc-tural characterization and guarantee the quality of biotherapeutics. Capillary electrophoresis (CE) is con-sidered today as a major technique for the analysis of biotherapeutics due to benefic characteristics as high resolution separation and miniaturized format. Different CE modes have been developed to charac-terize mAbs at different levels such as capillary gel electrophoresis (CGE), capillary isoelectric focusing (cIEF), and capillary zone electrophoresis (CZE). Recent developments in CE-mass spectrometry (MS) cou-pling assessed this technology as a promising tool to obtain high level structural characterization of bio-pharmaceuticals. Moreover, upcoming techniques such as 2D CE-MS and microfluidic systems are now emerging to offer new possibilities beyond actual limits. This review will be dedicated to discuss the state-of-the-art CE-based methods for the characterization of mAbs and ADCs in the period 2016-2018