Abstract
Abstract This chapter demonstrates the essential role of capillary electrophoresis (CE) in biopharmaceutical research, development, manufacturing, and release of therapeutic biomolecules. Three main separation techniques − CE-SDS, cIEF, and CZE − are discussed. Detailed method development examples based on four analytical release methods commonly used in the biotech industry are illustrated for the determination of product purity, identity, and consistency. Considerations for method qualification, transfer, and validation are also discussed. Practical examples, for troubleshooting including abnormal electropherograms, are presented from experience gained during method development and transfer. Although CE methods are relatively new to the highly regulated quality control (QC) environment, our experience demonstrates that they can be adapted to this environment with proper analyst training, detailed standard operating procedures, and specific system suitability and sample acceptance criteria. The superior performance of CE over traditional slab-gel methods demonstrates a great advancement for the overall quality release of biopharmaceutical molecules.
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