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


These data demonstrate that the Prolastin-C manufacturing process has a high capacity to inactivate and/or remove a diverse variety of enveloped and non-enveloped virus challenges as well as infectious prions. The novel solvent/detergent treatment step provides robust


inactivation of enveloped viruses while maintaining alpha1-proteinase inhibitor activity. The 15nm nanofiltration step introduces a robust, dedicated orthogonal step for removal of viruses. Three steps common to the Prolastin and Prolastin-C manufacturing processes, cold ethanol fractionation, PEG precipitation, and depth filtration, also contribute to the reduction of viruses as well as TSE infectivity. Therefore, the Prolastin-C manufacturing process provides the product with a high demonstrated margin of safety from the risk for transmission of infectious agents. n


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Nathan J Roth, PhD, is the Director of Pathogen Safety, overseeing the Viral Validation, TSE, and Support and Compliance sections within the Talecris Pathogen Safety department. He is a biochemist/microbiologist by training, having earned a BS degree in cellular, molecular, and microbial biology and a PhD in biochemistry from the University of Calgary. Prior to joining Talecris, Dr Roth was part of a team of scientists at VI Technologies involved in the development of novel methods for inactivation of


viruses and protozoa and removal of transmissible spongiform encephalopathy (TSE) pathogens from blood components. He also gained relevant experience in biopharmaceutical process development at Centeon (now CSL Behring), where he co-invented a patented method for preparing a diafiltered stabilized blood product. Dr Roth is a member of the Parenteral Drug Association (PDA) and serves on the Pathogen Safety Steering Committee of the Plasma Protein Therapeutics Association (PPTA).


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