title: Effective virus inactivation and removal by steps of Biotest Pharmaceuticals IGIV production process.
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.
authors.affiliation: Pathogen Safety Department, Biotest AG, Dreieich, Germany.
authors.forename: Herbert O
authors.initials: HO
authors.lastname: Dichtelmüller
authors.affiliation: Pathogen Safety Department, Biotest AG, Dreieich, Germany.
authors.forename: Eckhard
authors.initials: E
authors.lastname: Flechsig
authors.affiliation: Development Department, Biotest Pharmaceuticals, Boca Raton, FL, USA.
authors.forename: Frank
authors.initials: F
authors.lastname: Sananes
authors.affiliation: Quality Assurance Department, Biotest AG, Dreieich, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Kretschmar
authors.affiliation: Clinical Research Department, Biotest Pharmaceuticals, Boca Raton, FL, USA.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Dougherty
keywords: Cold ethanol fractionation; Intravenous immunoglobulin; Low pH; Solvent/detergent; Virus filtration; Virus inactivation