Process and product monitoring of recombinant DNA-derived biopharmaceuticals with high-performance capillary electrophoresis.

High-performance capillary electrophoresis (HPCE) has emerged over the past 20 years as a powerful multidimensional separation tool that is orthogonal to HPLC and comparable to sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) slab gel methods. HPCE is most frequently applied in the QC release testing of recombinant DNA-derived protein and monoclonal antibody (MAb) biopharmaceuticals. HPCE is a rugged and robust separation tool that can be used like HPLC to monitor the purification process, as well as to analyze bulk drug and drug substances.