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.
Laboratoire de Spectrométrie de Masse des Interactions et des Systèmes (LSMIS), Unistra-CNRS UMR 7140, Université de Strasbourg, Strasbourg, France; Division of BioAnalytical Chemistry, AIMMS Research Group BioMolecular Analysis, VU University Amsterdam, Amsterdam, The Netherlands.
Rabah
R
Gahoual
Centre d'Immunologie Pierre Fabre, Saint-Julien-en-Genevois, France.
Alain
A
Beck
Laboratoire de Spectrométrie de Masse des Interactions et des Systèmes (LSMIS), Unistra-CNRS UMR 7140, Université de Strasbourg, Strasbourg, France.
Emmanuelle
E
Leize-Wagner
Laboratoire de Spectrométrie de Masse des Interactions et des Systèmes (LSMIS), Unistra-CNRS UMR 7140, Université de Strasbourg, Strasbourg, France. Electronic address: yfrancois@unistra.fr.
Yannis-Nicolas
YN
François
D000818:Animals; D000911:Antibodies, Monoclonal / Q000737:chemistry*; D059451:Biosimilar Pharmaceuticals / Q000737:chemistry*; D019075:Electrophoresis, Capillary / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D018796:Immunoconjugates / Q000737:chemistry*; D007525:Isoelectric Focusing / Q000295:instrumentation / Q000379:methods; D013058:Mass Spectrometry / Q000295:instrumentation / Q000379:methods
D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; D018796:Immunoconjugates
Antibody; Biosimilar; Capillary gel electrophoresis; Capillary isoelectric focusing; Capillary zone; Drug conjugate; Electrophoresis; Fc-fusion protein; Mass spectrometry; Monoclonal antibodies