Premium
CE‐SDS method development, validation, and best practice—An overview
Author(s) -
Sänger–van de Griend Cari E.
Publication year - 2019
Publication title -
electrophoresis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.666
H-Index - 158
eISSN - 1522-2683
pISSN - 0173-0835
DOI - 10.1002/elps.201900094
Subject(s) - troubleshooting , biopharmaceutical , license , biochemical engineering , best practice , mechanism (biology) , computer science , risk analysis (engineering) , chromatography , computational biology , chemistry , engineering , microbiology and biotechnology , business , biology , political science , philosophy , epistemology , law , operating system
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.