Cutting edge capillary electrophoresis characterization of monoclonal antibodies and related products.
Out of all categories, monoclonal antibodies (mAbs) biosimilar, antibody drug conjugates (ADCs) and Fc fusion proteins attract the most interest due to their strong therapeutic potency and specificity. Because of their intrinsic complexity due to a large number of micro heterogeneities, there is a crucial need of analytical methods to provide comprehensive in depth characterization of these molecules. CE presents some obvious benefits as high resolution separation and miniaturized format to be widely applied to the analysis of biopharmaceuticals. CE is an effective method for the separation of proteins at different levels. capillary gel electrophoresis (CGE) capillary isoelectric focusing (cIEF) and capillary zone electrophoresis (CZE) have been particularly relevant for the characterization of size and charge variants of intact and reduced mAbs, while CE MS appears to be a promising analytical tool to assess the primary structure of mAbs and related products. This review will be dedicated to detail the current and state of the art CE based methods for the characterization of mAbs and related products.
Journal of chromatography. B, Analytical technologies in the biomedical and life sciences