Effective virus inactivation and removal by steps of Biotest Pharmaceuticals IGIV production process

Autor:	Christopher J. Dougherty, Eckhard Flechsig, Michael Kretschmar, Herbert O. Dichtelmüller, Frank Sananes
Rok vydání:	2012
Předmět:	Virus filtration Virus inactivation Chromatography Chemistry viruses Immunology Fraction (chemistry) Fractionation Article Virus law.invention Chemical engineering Solvent/detergent law Low pH Solvent detergent Cold ethanol fractionation Intravenous immunoglobulin Filtration
Zdroj:	Results in Immunology
ISSN:	2211-2839
DOI:	10.1016/j.rinim.2012.01.002
Popis:	The virus validation of three steps of Biotest Pharmaceuticals IGIV production process is described here. The steps validated are precipitation and removal of fraction III of the cold ethanol fractionation process, solvent/detergent treatment and 35nm virus filtration. Virus validation was performed considering combined worst case conditions. By these validated steps sufficient virus inactivation/removal is achieved, resulting in a virus safe product.
Databáze:	OpenAIRE
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