SARS-CoV-2假病毒在生物技术药物有效性评价中的应用进展  

Research progress on application of SARS-CoV-2 pseudovirus in biotechnological drug effectiveness evaluation

作　　者：李甜甜 王灿(综述) 邵泓(审校) LI Tiantian;WANG Can;SHAO Hong(NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies,Shanghai Institute for Food and Drug Control,Shanghai201203,China)

机构地区：[1]上海市食品药品检验研究院国家药品监督管理局治疗类单抗质量控制重点实验室,上海201203

出　　处：《中国生物制品学杂志》2024年第8期1008-1013,1019,共7页Chinese Journal of Biologicals

基　　金：上海市科委“科技创新行动计划”(21142202900);上海市研发公共服务平台项目(19DZ2294600).

摘　　要：目前,SARS-CoV-2仍在不断发生变异,致病能力虽然减弱,但传播能力更快,对人类健康仍存在威胁。抗SARS-CoV-2生物技术药物仍是生物医药领域的研发热点,有效性评价对这些药物的筛选至关重要。传统的抗SARS-CoV-2生物技术药物有效性评价需采用SARS-CoV-2活病毒,活病毒获取困难,实验条件要求高,限制了抗SARSCoV-2生物技术药物的研发速度。SARS-CoV-2假病毒可模拟活病毒的感染性,但不具有活病毒的传染性,安全性较高,易于制备,是抗SARS-CoV-2生物技术药物有效性评价的有利工具。本文就SARS-CoV-2流行病学特征、SARSCoV-2假病毒包装体系及该假病毒在生物技术药物有效性评价中的应用进展作一综述,以期为SARS-CoV-2假病毒用于生物技术药物的研发及质量评价提供参考。At present,SARS-CoV-2 is still constantly evolving and mutating,with weakened pathogenicity but faster transmis-sion,which still threatens human health.Anti-SARS-CoV-2 biotechnological drugs are still the hotspot of research and develop-ment in the field of biomedicine,and the effectiveness evaluation is very important for screening these drugs.Traditional effectiveness evaluation of anti-SARS-CoV-2 biotechnological drugs requires the live virus of SARS-CoV-2 that is difficult to obtain,and the requirement of high experimental conditions has limited the research and development of anti-SARS-CoV-2 biotechnological drugs.SARS-CoV-2 pseudovirus can simulate the infectivity of live virus,but it has no infectivity oflive virus,and is safe and easy to prepare,which is a favorable tool for evaluating the effectiveness of SARS-CoV-2 biotechnological drugs.In this paper,the epidemiological characteristics of SARS-CoV-2,the packaging system of SARS-CoV-2 pseudovirus and the application of SARS-CoV-2 pseudovirus in the effectiveness evaluation of biotechnological drugs were reviewed,so as to provide a reference for the application of SARS-CoV-2 pseudovirus in the development and quality evaluation of bio-technological drugs.

关 键 词：SARS-CoV-2 假病毒 假病毒包装系统 生物技术药物 有效性 

分 类 号：R917[医药卫生—药物分析学]