Biotest制药公司静脉注射免疫球蛋白（IGIV）生产过程各步骤对病毒的有效灭活和去除
Effective virus inactivation and removal by steps of Biotest Pharmaceuticals IGIV production process.
作者信息
Dichtelmüller Herbert O, Flechsig Eckhard, Sananes Frank, Kretschmar Michael, Dougherty Christopher J
机构信息
Pathogen Safety Department, Biotest AG, Dreieich, Germany.
Development Department, Biotest Pharmaceuticals, Boca Raton, FL, USA.
出版信息
Results Immunol. 2012 Jan 16;2:19-24. doi: 10.1016/j.rinim.2012.01.002. eCollection 2012.
Abstract
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.
摘要
本文介绍了百泰药业静脉注射免疫球蛋白（IGIV）生产过程三个步骤的病毒验证情况。经验证的步骤包括冷乙醇分级分离过程中沉淀和去除Ⅲ组分、溶剂/去污剂处理以及35纳米病毒过滤。病毒验证是在综合考虑最坏情况条件下进行的。通过这些经验证的步骤可实现充分的病毒灭活/去除，从而生产出病毒安全的产品。
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