Literature DB >> 24371563

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

Herbert O Dichtelmüller1, Eckhard Flechsig1, Frank Sananes2, Michael Kretschmar3, Christopher J Dougherty4.   

Abstract

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 35 nm 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.

Entities:  

Keywords:  Cold ethanol fractionation; Intravenous immunoglobulin; Low pH; Solvent/detergent; Virus filtration; Virus inactivation

Year:  2012        PMID： 24371563      PMCID： PMC3862342          DOI： 10.1016/j.rinim.2012.01.002

Source DB:  PubMed          Journal:  Results Immunol        ISSN： 2211-2839


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