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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… Click to show full abstract
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.
Keywords:
development validation;
method development;
overview
Journal Title: ELECTROPHORESIS
Year Published: 2019
Link to full text (if available)
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Journal Title: ELECTROPHORESIS
Year Published: 2019
Link to full text (if available)
Share on Social Media: Sign Up to like & get
recommendations!