重组表达生物制品病毒安全性研究与评价的考虑  

Considerations on research and evaluation of virus safety for recombinant biological products

作　　者：韦薇[1] 徐隆昌 白玉[1] 罗建辉[1] WEI Wei;XU Long-chang;BAI Yu;LUO Jian-hui(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《中国新药杂志》2019年第16期1964-1968,共5页Chinese Journal of New Drugs

摘　　要：随着生物技术的蓬勃发展,重组表达生物制品应用于越来越多的疾病治疗领域,且发挥着较好的治疗效果。为了获得高产量、高质量的重组表达蛋白,人们利用肿瘤细胞株作为宿主细胞,通过基因工程改造的方法,表达目的蛋白。然而,细胞在培养的过程中,存在内源性和外源性病毒污染产品的风险,因此重组表达生物制品在工艺研发和质量研究与评价的一个重要方面就是病毒安全性的研究与评价。本文综述重组表达生物制品病毒安全性研究与评价的一些考虑。With the development of biotechnology,recombinant biological products are applied in more and more disease areas and have achieved good effects in recent years. In order to get high productivity and high quality recombinant proteins,people take the advantage of tumor cells as production cells and harvest target proteins by gene manipulation. However,there is risk of contamination by endogenous and adventitious viruses during the production,therefore,research and evaluation of virus safety is one of the most important parts during the manufacturing process research and development. This article will provide some considerations on virus safety research and evaluation for the production of recombinant biological products.

关 键 词：重组表达生物制品 病毒安全性 研究与评价 

分 类 号：R965.3[医药卫生—药理学]