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

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Veröffentlicht in:	Journal of pharmaceutical sciences 2010-05, Vol.99 (5), p.2200-2208
Hauptverfasser:	Carpenter, John F., Randolph, Theodore W., Jiskoot, Wim, Crommelin, Daan J.A., Middaugh, C.Russell, Winter, Gerhard
Format:	Artikel
Sprache:	eng
Schlagworte:	analytical biochemistry analytical ultracentrifugation Biological and medical sciences biophysical models Chromatography, Gel - methods Chromatography, Gel - standards Drug Stability General pharmacology high‐performance/pressure liquid chromatography (HPLC) Medical sciences Pharmaceutical Preparations - analysis Pharmaceutical Preparations - chemistry Pharmaceutical Preparations - standards Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments physical stability protein aggregation protein formulation Protein Stability Quality Control Recombinant Proteins - analysis Recombinant Proteins - chemistry Recombinant Proteins - standards
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