McAlister M, Aranha H, Larson R
Scientific and Laboratory Services (SLS), Pall Corporation, Port Washington, NY 11050, USA.
Dev Biol (Basel). 2004;118:89-98.
The threat of viral contamination is common to all processes using biological products of animal or human origin. Therefore, demonstration of virus clearance (i.e. validation of virus removal and/or inactivation steps) is of utmost importance to the biopharmaceutical industries. Ultimately, virus clearance studies should show that any virus removal/inactivation stage incorporated into the manufacturing process not only removes or inactivates known viruses that may be conceivably present (e.g. from cell banks and source materials), but also other viruses that may be introduced adventitiously (e.g. by addition of supplements downstream of the manufacturing process). In this paper, we outline the shared properties of mammalian viruses and similar sized bacteriophages, and factors that may influence the virus clearance process. We also present test data from filtration studies, showing similar titre reductions for both types of virus. We propose that well-characterised bacteriophage, such as PP7 and PR772 can be used as models for mammalian viruses if the virus removal mechanism is based on size exclusion.
病毒污染的威胁在所有使用动物或人类源生物制品的工艺中都很常见。因此，证明病毒清除（即验证病毒去除和/或灭活步骤）对生物制药行业至关重要。最终，病毒清除研究应表明，纳入生产工艺的任何病毒去除/灭活阶段不仅要去除或灭活可能存在的已知病毒（例如来自细胞库和原料），还要去除或灭活可能偶然引入的其他病毒（例如在生产工艺下游添加补充剂时引入的病毒）。在本文中，我们概述了哺乳动物病毒和类似大小噬菌体的共同特性，以及可能影响病毒清除过程的因素。我们还展示了过滤研究的测试数据，表明两种病毒的滴度降低情况相似。我们建议，如果病毒去除机制基于尺寸排阻，那么像PP7和PR772这样特征明确的噬菌体可以用作哺乳动物病毒的模型。
