房恩岳,张丽萍,马雪征,胡孔新

• 1:中国检验检疫科学研究院

摘要(Abstract)：

慢病毒载体来源于人类免疫缺陷病毒，是一种强大的真核细胞基因修饰工具，有近30年的发展历史，多款基于慢病毒载体的CAR-T细胞疗法已获批上市，进一步推动了慢病毒载体的普及。但由于早期的慢病毒载体系统各质粒间或质粒与细胞基因组间可能发生重组而产生复制型慢病毒（Replication competent lentivirus,RCL），存在严重安全隐患，提高病毒载体安全性始终贯穿于整个病毒载体的改造历史。为保障慢病毒载体能安全有效地应用于临床，应对其质量进行充分研究。本文就慢病毒载体的改造历程进行综述，并介绍其在免疫细胞治疗中的应用及相关产品的质量研究，为慢病毒载体相关产品的质量和安全奠定基础。

关键词(KeyWords)： 人类I型免疫缺陷病毒(HIV-1);慢病毒载体;复制型慢病毒;嵌合抗原受体T细胞(CAR-T细胞);检测方法

Abstract:

Keywords:

基金项目(Foundation): 国家重点研发计划项目（项目号：2021YFC2600503）,题目：重要公共场所生物恐怖威胁因子现场防控新技术和新设备;; 北京市科技计划项目（项目号：Z221100005222007）,题目：新冠病毒环境气溶胶全自动核酸检测集成控制系统研究~~

作者(Author): 房恩岳,张丽萍,马雪征,胡孔新

DOI: 10.13242/j.cnki.bingduxuebao.004349

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