Herbert O. Dichtelmüller , Eckhard Flechsig , Frank Sananes , Michael Kretschmar , Christopher J. Dougherty
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Effective virus inactivation and removal by steps of Biotest Pharmaceuticals IGIV production process
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.
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