Capillary Electrophoresis

Capillary Electrophoresis refers to an analytical technique used to separate charged biomolecules such as proteins, peptides, and nucleic acids based on their size-to-charge ratio within a narrow capillary under an applied electric field. This method provides high-resolution separation and is widely applied for characterising complex biologics, identifying charge variants, and detecting impurities or degradation products. Capillary electrophoresis platforms include variants such as capillary zone electrophoresis, capillary gel electrophoresis, and capillary isoelectric focusing, each suited for specific molecular attributes and analytical objectives.

The biopharmaceutical industry relies extensively on capillary electrophoresis as a core characterisation tool for monoclonal antibodies and other recombinant proteins. It supports comparability assessments, stability studies, and lot-to-lot consistency monitoring by detecting subtle differences in product profiles that may affect safety or efficacy. Regulatory submissions often include capillary electrophoresis data as part of analytical method packages demonstrating product identity, purity, and heterogeneity. Its ability to deliver reproducible and quantitative results makes it valuable in both development and quality control settings. As biologics become more structurally complex and regulatory expectations for detailed characterisation increase, capillary electrophoresis continues evolving through automation, improved detection systems, and integration with orthogonal analytical techniques.