Potential inaccurate quantitation and sizing of protein aggregates by size exclusion chromatography: essential need to use orthogonal methods to assure the quality of therapeutic protein products

J Pharm Sci. 2010 May;99(5):2200-8. doi: 10.1002/jps.21989.

Authors

John F Carpenter¹, Theodore W Randolph, Wim Jiskoot, Daan J A Crommelin, C Russell Middaugh, Gerhard Winter

Affiliation

¹ Department of Pharmaceutical Sciences, Center for Pharmaceutical Biotechnology, University of Colorado Denver, Anschutz Medical Campus, Aurora, Colorado 80045, USA. john.carpenter@ucdenver.edu

PMID: 19918982
DOI: 10.1002/jps.21989

No abstract available

MeSH terms

Chromatography, Gel / methods*
Chromatography, Gel / standards
Drug Stability
Pharmaceutical Preparations / analysis*
Pharmaceutical Preparations / chemistry
Pharmaceutical Preparations / standards*
Protein Stability
Quality Control
Recombinant Proteins / analysis*
Recombinant Proteins / chemistry
Recombinant Proteins / standards*

Substances

Pharmaceutical Preparations
Recombinant Proteins