id author title date pages extension mime words sentences flesch summary cache txt cord-260147-w19hl2vs Gröner, Albrecht Effective inactivation of a wide range of viruses by pasteurization 2017-11-16 .txt text/plain 4285 204 33 STUDY DESIGN AND METHODS: The virus inactivation kinetics of pasteurization for a broad range of viruses were evaluated in the relevant intermediates from more than 15 different plasma manufacturing processes. The first reliable virus inactivation method, pasteurization (heat treatment in aqueous solution at 608C for 10 hr), to effectively inactivate HBV and HCV (at that time called non-A/non-B hepatitis virus) in coagulation factor concentrates was studied and implemented at Behringwerke (a predecessor company of CSL Behring) in the late 1970s and early 1980s by employing suitable stabilizers and conditions to permit pasteurization without modifying the product, for example, formation of neoantigens or activated factors. 11, 12 Virus validation guidelines were ultimately developed and issued by the European authorities, requiring manufacturers to carry out studies to demonstrate the capacity, reliability, and effectiveness of the manufacturing processes to inactivate and/or remove viruses potentially present in the starting material (plasma pool for fractionation). ./cache/cord-260147-w19hl2vs.txt ./txt/cord-260147-w19hl2vs.txt