假病毒技术在新突发病毒性传染病防控产品评价中的应用  

The Application of Pseudotyped Virus Technology in the Evaluation of Prevention and Control Products for New Emergent Viral Infectious Disease

作　　者：黄维金[1] 王佑春[1] HUANG Weijin;WANG Youchun(National Institutes for Food and Drug Control,Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products,Key Laboratory of Biological Product Quality Research and Evaluation of State Drug Administration,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,卫健委生物技术产品检定方法与标准化重点实验室,国家药品监督管理局生物制品质量研究与评价重点实验室,北京102629

出　　处：《病毒学报》2020年第6期1177-1186,共10页Chinese Journal of Virology

基　　金：国家重大新药创制重大科技专项课题(项目号:2018ZX09101001),题目:创新生物技术药物评价及标准化关键技术研究。

摘　　要：新发烈性病毒性传染病病原体的实验操作往往需要在高等级的生物安全实验室中进行,活病毒在实验室内操作和实验室间转移均具有较高的安全风险,导致采用活病毒进行疫苗、抗体药物的体外效力评价、筛选等受到影响。随着生物技术的提高,假病毒技术通过模拟病毒的膜结构或者模拟病毒核酸状态,前者模拟病毒感染的受体结合、细胞进入、抗体识别等过程,可替代活病毒进行体外细胞实验和动物体内实验,后者代替活病毒,用于核酸检测的质控品。本文将对假病毒技术在疫苗、抗体、诊断试剂等生物技术产品评价中的应用情况进行综述,以期为假病毒技术在SARS-CoV-2防控产品研究和评价中的应用提供借鉴。The experimental operation of new emergent infectious disease pathogens often needs to be carried out in a high-level biosafety laboratory.The laboratory operation of live virus and the transfer between labs bring a high level of safety risk,which results in difficulties with in vitro potency evaluation of vaccine and antibody drugs screening using live virus.With the improvement of biotechnology,pseudotyped virus technology can simulate the membrane structure of virus or the state of virus nucleic acid.The former can simulate the process of receptor binding,entering cell and antibody recognition of viral infection,and can replace the living virus for in vitro cell experiment and animal experiment in vivo.The latter can replace the living virus for quality control of nucleic acid detection.This paper reviews the application of pseudotyped virus technology in the evaluation of biotechnology products such as vaccines,antibodies,diagnostic reagents,etc.,in order to provide reference for the application of pseudotyped virus technology in the basic research and product evaluation of SARS-CoV-2 prevention and control.

关 键 词：新突发传染病 SARS-CoV-2 假病毒 疫苗 中和抗体 

分 类 号：R373[医药卫生—病原生物学] R511[医药卫生—基础医学]