Capillary electrophoresis and the biopharmaceutical industry: Therapeutic protein analysis and characterization

Capillary electrophoresis (CE) has emerged as a powerful technique for comprehensive physicochemical characterization of monoclonal antibodies (mAbs) as well as other therapeutic modalities. The method provides high resolution separation and high sensitivity characterization for analysis of therapeutic biomolecules. CE based techniques such as sodium dodecyl sulphate capillary gel electrophoresis (SDS-CGE, also referred to as CE SDS), capillary zone electrophoresis (CZE) and imaged capillary isoelectric focusing (iCIEF) have been increasingly adopted to assess size heterogeneity, glycosylation heterogeneity and charge heterogeneity in mAbs and related therapeutic modalities. This paper reviews the latest application developments of CE based methods for routine release testing, stability testing and in-depth characterization. In addition, advantages and disadvantages of each of these techniques are critically discussed. (c) 2021 The Author(s). Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Automated summary

Capillary electrophoresis is a powerful technique for comprehensive physicochemical characterization of therapeutic biomolecules, such as monoclonal antibodies, providing high resolution separation and high sensitivity characterization. Techniques like SDS-CGE, CZE, and iCIEF are increasingly used to assess heterogeneity in mAbs and related therapeutic modalities, with advantages and disadvantages that are critically discussed.