Abstract

The use of capillary electrophoresis (CE) for the analysis of therapeutic proteins produced by recombinant DNA technology has significantly increased over the past several years. In this chapter, a summary of the most important CE applications implemented at Genentech, Inc. is presented. The applications reviewed in this work are divided into the following areas: (i) capillary electrophoresis sodium dodecyl sulfate as a replacement for traditional SDS-PAGE, (ii) CE to monitor charge heterogeneity by capillary zone electrophoresis and capillary isoelectric focusing, and (iii) analysis of N-linked oligosaccharides release from an rMAb by CE. Finally, an overview of the implementation of CE in the quality control of therapeutic proteins is described.

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