Abstract
Biopharmaceuticals represent a category of therapeutic products with a remarkable potential to treat disease and the number of approved products is increasing at a rapid rate. The characterization of biopharmaceutical products remains challenging because of their large size, structural complexity in addition to a propensity to exhibit a wide range of micro-heterogeneities. The properties of capillary electrophoresis (CE) separation are particularly relevant for the analysis of biomolecules therefore it is quite interesting for the characterization of biopharmaceutical proteins on complementary levels. Capillary gel electrophoresis, capillary isoelectric focusing and capillary zone electrophoresis are used in routine and demonstrated their reliability for the analysis of charge and size variants of therapeutic products. Recent developments have highlighted the potential of CE-MS for primary structure assessment and the characterization of post-translational modifications. The applications detailed in this chapter reveal the importance of CE methods in the panel of analytical techniques necessary to perform a comprehensive characterization of biopharmaceutical products.
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