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.

毛细管电泳 (CE) 已成为一种强大的技术，可用于对单克隆抗体 (mAb) 以及其他治疗方式进行全面的物理化学表征。该方法为治疗性生物分子的分析提供了高分辨率分离和高灵敏度表征。基于 CE 的技术，如十二烷基硫酸钠毛细管凝胶电泳 (SDS-CGE，也称为 CE SDS)、毛细管区带电泳 (CZE) 和成像毛细管等电聚焦 (iCIEF) 已越来越多地用于评估大小异质性、糖基化异质性和单克隆抗体和相关治疗方式中的电荷异质性。本文回顾了基于 CE 的方法在常规放行测试、稳定性测试和深入表征方面的最新应用进展。此外，