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生物制品生产中的病毒污染及其对新兴疗法的影响
2020-04-30 11:03

美国麻省理工学院的Stacy L. Springs等研究人员总结了生物制品生产中的病毒污染及其对新兴疗法的影响。2020年4月27日,相关论文在线发表于《自然—生物技术》杂志上。

据研究人员介绍,重组蛋白治疗剂、疫苗和血浆产品具有悠久的安全历史。然而,使用细胞培养产生重组蛋白仍然容易受到病毒的污染。这些污染需要花费数百万美元才能清除,也可能导致患者无法接受治疗,而且出现得非常罕见,这使得前车之鉴难以实现。

研究人员表示,由生物技术公司组成的联盟与麻省理工学院一起,召集了有关这些事件的数据。这项涵盖整个行业的研究提供了有关最常见病毒污染物、污染物的来源、受影响的细胞系、纠正措施以及此类事件影响的见解。这些结果不仅对安全有效地生产当前产品具有影响,而且对新兴的细胞和基因疗法也有意义。

附:英文原文

Title: Viral contamination in biologic manufacture and implications for emerging therapies

Author: Paul W. Barone, Michael E. Wiebe, James C. Leung, Islam T. M. Hussein, Flora J. Keumurian, James Bouressa, Audrey Brussel, Dayue Chen, Ming Chong, Houman Dehghani, Lionel Gerentes, James Gilbert, Dan Gold, Robert Kiss, Thomas R. Kreil, Ren Labatut, Yuling Li, Jrgen Mllberg, Laurent Mallet, Christian Menzel, Mark Moody, Serge Monpoeho, Marie Murphy, Mark Plavsic, Nathan J. Roth, David Roush, Michael Ruffing, Richard Schicho, Richard Snyder, Daniel Stark, Chun Zhang, Jacqueline Wolfrum, Anthony J. Sinskey, Stacy L. Springs

Issue&Volume: 2020-04-27

Abstract: Recombinant protein therapeutics, vaccines, and plasma products have a long record of safety. However, the use of cell culture to produce recombinant proteins is still susceptible to contamination with viruses. These contaminations cost millions of dollars to recover from, can lead to patients not receiving therapies, and are very rare, which makes learning from past events difficult. A consortium of biotech companies, together with the Massachusetts Institute of Technology, has convened to collect data on these events. This industry-wide study provides insights into the most common viral contaminants, the source of those contaminants, the cell lines affected, corrective actions, as well as the impact of such events. These results have implications for the safe and effective production of not just current products, but also emerging cell and gene therapies which have shown much therapeutic promise.

DOI: 10.1038/s41587-020-0507-2

Source: https://www.nature.com/articles/s41587-020-0507-2

Nature Biotechnology:《自然—生物技术》,创刊于1996年。隶属于施普林格·自然出版集团,最新IF:68.164
官方网址:https://www.nature.com/nbt/
投稿链接:https://mts-nbt.nature.com/cgi-bin/main.plex


本期文章:《自然—生物技术》:Online/在线发表

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