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Applications of capillary electrophoresis in characterizing recombinant protein therapeutics

TitleApplications of capillary electrophoresis in characterizing recombinant protein therapeutics
Publication TypeJournal Article
Year of Publication2014
AuthorsZhao, SSherry, Chen, DDY
JournalELECTROPHORESIS
Volume35
Pagination96-108
Date PublishedJAN
ISSN0173-0835
Abstract

The use of recombinant protein for therapeutic applications has increased significantly in the last three decades. The heterogeneity of these proteins, often caused by the complex biosynthesis pathways and the subsequent PTMs, poses a challenge for drug characterization to ensure its safety, quality, integrity, and efficacy. CE, with its simple instrumentation, superior separation efficiency, small sample consumption, and short analysis time, is a well-suited analytical tool for therapeutic protein characterization. Different separation modes, including CIEF, SDS-CGE, CZE, and CE-MS, provide complementary information of the proteins. The CE applications for recombinant therapeutic proteins from the year 2000 to June 2013 are reviewed and technical concerns are discussed in this article.

DOI10.1002/elps.201300372