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Research Article
Development, validation, and implementation of capillary gel electrophoresis as a replacement for SDS-PAGE for purity analysis of IgG2 mAbs
Article first published online: 19 JAN 2010
DOI: 10.1002/jssc.200900597
Copyright © 2010 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim
Additional Information
How to Cite
Lacher, N. A., Roberts, R. K., He, Y., Cargill, H., Kearns, K. M., Holovics, H. and Ruesch, M. N. (2010), Development, validation, and implementation of capillary gel electrophoresis as a replacement for SDS-PAGE for purity analysis of IgG2 mAbs. J. Sep. Science, 33: 218–227. doi: 10.1002/jssc.200900597
Publication History
- Issue published online: 1 FEB 2010
- Article first published online: 19 JAN 2010
- Manuscript Revised: 4 NOV 2009
- Manuscript Accepted: 4 NOV 2009
- Manuscript Received: 16 SEP 2009
- Abstract
- Article
- References
- Cited By
Keywords:
- Antibody IgG2;
- CE;
- Qualification
Abstract
Capillary gel electrophoresis (CGE) methods with UV detection were developed for reduced and non-reduced mAb analysis. These methods can be used to evaluate mAb purity, offering more reproducible quantitation compared with that of traditional SDS-PAGE methods. These CGE methods have been utilized as platform technology for bioprocess development, formulation development, mAb characterization, drug substance/drug product release testing as well as a required methodology for stability testing. We have found these CGE methods to be applicable across a platform of mAbs in preclinical and clinical development, with the majority of mAbs requiring no modification to the method conditions. This methodology has been ICH validated and transferred to several supporting organizations. The data presented herein describes the development of CGE methodology, platform application to mAb purity analysis, ICH validation, reliability metrics, and considerations on technology enhancement for improved performance and throughput.