Validation of a Prion and Virus Purification Process in the Manufacture of Bovine Thrombin

نویسنده

  • Abdel Terrab
چکیده

Background: To further minimize transmission risk of blood-borne viral and prion diseases, manufacturers of therapeutic animalor human-derived proteins have implemented improved in-process pathogen-removal procedures. Objectives: To evaluate removal of transmissible spongiform encephalopathy agents (prions) and viruses using Omega 100K VR membrane filtration system (Pall Filtron, Northborough, MA) during manufacture of bovine thrombin. Methods: Purified bovine thrombin was challenged with a high-titer clarified brain homogenate of the 263K hamster scrapie strain, a model for bovine transmissible spongiform encephalopathy agents, and 4 representative model viruses: bovine parvovirus (BPV), xenotropic murine leukemia virus (XMuLV), pseudorabies virus (PRV), and bovine viral diarrhea virus (BVDV). Using a

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تاریخ انتشار 2007