浅析国内溶瘤病毒产品生产工艺和质量控制面临的挑战

Challenge Analysis of Oncolytic Viruses in Manufacturing Process and Quality Control in China

目的溶瘤病毒(oncolytic viruses,OVs)是一类具有复制能力、可选择性杀伤肿瘤细胞的病毒,其主要包括:野生的、减毒的具有天然嗜肿瘤特性的病毒,以及进行基因工程改造后具有嗜肿瘤特性的病毒。笔者结合个人工作进行总结和思考,以期促进国内OVs产品的研发和临床转化。方法笔者以国内临床应用的4类OVs(单纯疱疹病毒、腺病毒、呼肠孤病毒、痘苗病毒)为例,浅析OVs产品在生产工艺和质量控制方面存在的问题和面临的挑战。结果与结论本文围绕4类OVs结构特点、基因改造方法、生产工艺和质量研究存在挑战,以及审评建议进行阐述,希望与业界共同讨论,以加快国内OVs产业更好更快发展。

OBJECTIVE To put forward suggestions for promoting the development and clinical transformation of oncolytic viruses(OVs).METHODS This article is based on four types of viruses(herpes simplex virus,adenovirus,mammalian orthorrovirus,vaccinia virus)that have been approved for clinical trial in China,and analyzed the problems and challenges of manufacturing process and quality control.RESULT AND CONCLUSION The article focuses on the structural characteristics,genetic modification methods,challenges of manufacturing process and quality control,and review considerations of four OVs.We're expecting expedite development of OVs in domestic by discussing with developer who are making progress on it.