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.
Carpenter
John F
JF
Department of Pharmaceutical Sciences, Center for Pharmaceutical Biotechnology, University of Colorado Denver, Anschutz Medical Campus, Aurora, Colorado 80045, USA. john.carpenter@ucdenver.edu
Randolph
Theodore W
TW
Jiskoot
Wim
W
Crommelin
Daan J A
DJ
Middaugh
C Russell
CR
Winter
Gerhard
G
D002850:Chromatography, Gel / Q000379:methods* / Q000592:standards; D004355:Drug Stability; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry / Q000592:standards*; D055550:Protein Stability; D011786:Quality Control; D011994:Recombinant Proteins / Q000032:analysis* / Q000737:chemistry / Q000592:standards*
D004364:Pharmaceutical Preparations; D011994:Recombinant Proteins