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.

Authors :: Carpenter JF
Randolph TW
Jiskoot W
Crommelin DJ
Middaugh CR
Winter G
Source :: Journal of pharmaceutical sciences [J Pharm Sci] 2010 May; Vol. 99 (5), pp. 2200-8.
Publication Year :: 2010

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

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