高等级病原微生物实验室在生物医药领域的应用研究  

The Application of High-level Biosafety Laboratories in the Field of Biomedicine Research

作　　者：代航 刘莎 叶强[1] 陈晨[3] 黄洋[1] 王劲松[1] 姜晶钰 牛群 史宇辰 徐潇[1] 陈国庆[1] Dai Hang;Liu Sha;Ye Qiang;Chen Chen;Huang Yang;Wang Jinsong;Jiang Jingyu;Niu Qun;Shi Yuchen;Xu Xiao;Chen Guoqing(National Institutes for Food and Drug Control,Beijing 102629,China;School of Basic Medical Sciences,Capital Medical University,Beijing 100069,China;Institute of Medical biology Chinese Academy of Medical Sciences,Kunming 650118,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]首都医科大学基础医学院,北京100069 [3]中国医学科学院医学生物学研究所,昆明650118

出　　处：《中国药事》2024年第3期298-306,共9页Chinese Pharmaceutical Affairs

基　　金：国家重点研发计划《媒介生物及其宿主环境相关病原菌与样本资源库构建关键支撑技术研究及应用示范》(编号2022YFC2602203);国家科技资源共享服务平台《国家病原微生物资源库》(编号国家病原微生物资源库-NPRC-32)。

摘　　要：目的:介绍烈性传染病病原体的诊断试剂、疫苗、治疗药物的研发和评价基本情况,突出高等级病原微生物实验室作为科技支撑和产业成果转化的重要作用,阐释高等级病原微生物实验室在生物医药领域的广阔应用前景。方法:分析国内外应对烈性传染病流行的重要措施,梳理高等级病原微生物实验室在诊断试剂、疫苗、治疗药物的研发和评价中发挥的重要作用,阐明提前布局医药产业发展、强化高等级实验室能力建设的方法。结果与结论:应充分发挥高等级病原微生物实验室在生物医药领域的基础设施作用,提前布局我国新发突发传染病病原体的检测鉴定、预防控制、药物治疗的前瞻性技术储备。这是应对SARS、MERS、EBHF、COVID-19等高致病性新发突发传染病引发的全球重大公共卫生问题的重要保障,也是有效防范化解生物安全风险,筑牢国家安全的重要举措。高等级病原微生物实验室在生物医药领域具有广阔的应用前景。Objective:To introduce the research of the development and evaluation of diagnostic reagents,vaccines,and therapeutic drugs for pathogens of severe infectious diseases,to highlight the important role of highgrade pathogenic microbiology laboratories as scientifi c and technological support and industrial achievements transformation,as to explain the broad application prospects of high-grade pathogenic microorganism laboratories in the field of biomedicine.Methods:The important measures to deal with the epidemic of severe infectious diseases at home and abroad were analyzed,the important role played by high-level pathogenic microbiological laboratories in the research and development and evaluation of diagnostic reagents,vaccines and therapeutic drugs was sorted out and the methods of advancing the development of pharmaceutical industry and strengthening the capacity building of high-level laboratories were expounded.Results and Conclusion:We should give full play to the infrastructure role of high-level pathogenic microorganism laboratories in the field of biomedicine,and advance the layout of prospective technical reserves for the detection,identifi cation,prevention and control,and drug treatment of emerging infectious disease pathogens in China.This is an important guarantee for tackling major global public health problems caused by highly pathogenic emerging infectious diseases such as SARS,MERS,EBHF and COVID-19.It is also an important measure to effectively prevent and defuse biosecurity risks and strengthen national security.Therefore,high-level pathogenic microorganism laboratories have broad application prospects in the fi eld of biomedicine.

关 键 词：高等级病原微生物实验室 传染病体外诊断试剂 疫苗 治疗药物 

分 类 号：R95[医药卫生—药学]