CE-SDS method development, validation, and best practice-An overview.

CE-SDS has been implemented in the biopharmaceutical industry and is being used for the characterization of therapeutic proteins in most Biological License Applications currently submitted. An overview is presented on the separation mechanism, methodology, and good working practices/best practices. The CE-SDS platform method development and validation are discussed and typical scientifically and regulatory issues and troubleshooting situations are highlighted.