Virus and Prion Safety of a New Preparation of Human Alpha1-proteinase Inhibitor, Prolastin®-C

The manufacture of Prolastin®-C (alpha1-proteinase inhibitor [human]) uses a modified process for Prolastin® that incorporates two new dedicated virus reduction steps: a unique solvent/detergent treatment and a small pore nanofiltration. The Prolastin-C manufacturing process was investigated for its capacity to remove or inactivate relevant viruses or models of relevant viruses by evaluating individual process steps across production ranges for key operating parameters. To address the theoretical risk of prion transmission, the Prolastin-C process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy, considered as a model for the variant Creutzfeldt–Jakob disease and Creutzfeldt–Jakob disease agents. These studies demonstrate that the manufacturing process for Prolastin-C maintains a high safety margin from the risk of transmission of infectious viruses with a wide range of physicochemical properties and maintains the capacity to effectively remove prions, if present in the starting material.