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

机译：通过Biotest Pharmaceuticals IGIV生产过程的步骤有效地灭活病毒并去除病毒

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摘要

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.

机译：此处介绍了Biotest Pharmaceuticals IGIV生产过程的三个步骤的病毒验证。验证的步骤是沉淀和去除冷乙醇分馏过程的第III部分，溶剂/洗涤剂处理和35 nm病毒过滤。考虑到最坏的情况，对病毒进行了验证。通过这些经过验证的步骤，可以实现足够的病毒灭活/去除，从而产生病毒安全的产品。

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期刊名称 Results in Immunology
作者
Herbert O. Dichtelmüller; Eckhard Flechsig; Frank Sananes; Michael Kretschmar; Christopher J. Dougherty;
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作者单位

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年(卷),期 2012(2),-1
年度 2012
页码 19–24
总页数 6
原文格式 PDF
正文语种
中图分类免疫学;
关键词
Intravenous immunoglobulin Cold ethanol fractionation Virus filtration Solvent/detergent Low pH Virus inactivation;

机译：静脉内免疫球蛋白;冷乙醇分级分离;病毒过滤;溶剂/去污剂;低pH;病毒灭活;

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2. Effects of the processing steps on parathion levels during honey production and parathion removal by macroporous adsorption resins. [J] . Ruihan Xu Ni Cheng Wei Huang Hui Gao Jianjun Deng Wei Cao Food Control . 2012,第1期

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3. Effective inactivation of Nipah virus in serum samples for safe processing in low-containment laboratories [J] . Shumpei Watanabe, Shuetsu Fukushi, Toshihiko Harada, Virology Journal . 2020,第1期

机译：血清样品中NIPAH病毒的有效灭活，用于低遏制实验室安全加工
4. Process considerations for Protein A affinity capture, virus inactivation, and linked polishing steps in multi-column continuous purification of monoclonal antibodies [C] . Robert Mierendorf, Tom Van Oosbree, Anthony Grabski, Conference on single-use technologies II: bridging polymer science to biotechnology applications . 2017

机译：多列连续单克隆抗体纯化中蛋白质A亲和力捕获，病毒灭活和关联的纯化步骤的工艺注意事项
5. Inactivation of murine norovirus on green onions and in salsa by high pressure processing, and inactivation of Salmonella on blueberries by a novel ultraviolet light and washing process [D] . Sido, Robert 2014

机译：通过高压处理灭活大葱和莎莎中的鼠诺如病毒，并通过新型的紫外线和洗涤方法灭活蓝莓上的沙门氏菌
6. Effective coronavirus reduction by various production steps during the manufacture of plasma‐derived medicinal products [O] . Tobias Schräder, Julia Koch, Rachael Ross, -1

机译：在血浆衍生药物产品的生产过程中通过各种生产步骤有效减少冠状病毒
7. Effective virus inactivation and removal by steps of Biotest Pharmaceuticals IGIV production process [O] . Dichtelmüller Herbert O., Flechsig Eckhard, Sananes Frank, 2012

机译：通过Biotest Pharmaceuticals IGIV生产过程的步骤有效地灭活病毒并去除病毒

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

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