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Effective virus inactivation and removal by steps of Biotest Pharmaceuticals IGIV production process

Results in immunology Pub Date : 2012-01-01 DOI:10.1016/j.rinim.2012.01.002
Herbert O. Dichtelmüller , Eckhard Flechsig , Frank Sananes , Michael Kretschmar , Christopher J. Dougherty
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引用次数: 12

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.

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Biotest Pharmaceuticals IGIV生产过程中有效的病毒灭活和去除步骤
这里描述了Biotest Pharmaceuticals IGIV生产过程的三个步骤的病毒验证。验证的步骤是冷乙醇分馏工艺的沉淀和去除馏分III，溶剂/洗涤剂处理和35 nm病毒过滤。考虑组合最坏情况进行病毒验证。通过这些经过验证的步骤，可以实现充分的病毒灭活/去除，从而生产出病毒安全的产品。
本文章由计算机程序翻译，如有差异，请以英文原文为准。
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Results in immunology
Results in immunology
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