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.

► Virus validation for a new immunoglobulin preparation for intravenous use.
► A combination of three different and robust virus inactivation/removal procedures is incorporated in the production process.
► Effective inactivation or removal of enveloped and non-enveloped viruses is demonstrated.
► The tested procedures have the potential to remove a broad range of emerging pathogens.