Cutting-edge capillary electrophoresis characterization of monoclonal antibodies and related products

Rabah Gahoual (1, 2, 3, 4) , Alain Beck (5) , Emmanuelle Leize-Wagner (2) , Yannis-Nicolas François (2)

1 TMS - Tectonique Moléculaire du Solide
2 CMC - Chimie de la matière complexe
3 Laboratoire de Chimie Quantique
4 Institut de Chimie de Strasbourg
5 CIPF - Centre d'Immunologie Pierre Fabre

: 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 bio-pharmaceuticals. CE is an effective method for the separation of proteins at different levels. capillary gel elec-trophoresis (CGE), capillary isoelectric focusing (cIEF) and capillary zone electrophoresis (CZE) have been par-ticularly 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.

Domaines: Chimie analytique

Rabah Gahoual, Alain Beck, Emmanuelle Leize-Wagner, Yannis-Nicolas François. Cutting-edge capillary electrophoresis characterization of monoclonal antibodies and related products. Journal of Chromatography B - Analytical Technologies in the Biomedical and Life Sciences, 2016, 1032, pp.61-78. ⟨10.1016/j.jchromb.2016.05.028⟩. ⟨hal-01981308⟩