文章摘要
代航,刘莎,叶强,陈晨,黄洋,王劲松,姜晶钰,牛群,史宇辰,徐潇,陈国庆.高等级病原微生物实验室在生物医药领域的应用研究[J].中国药事,2024,38(3):298-306
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 BiomedicineResearch
投稿时间:2023-06-30  
DOI:10.16153/j.1002-7777.2024.03.008
中文关键词: 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
英文关键词: high-level pathogenic microorganism laboratory  IVD  vaccines  therapeutic drugs
基金项目: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)
作者单位
代航 中国食品药品检定研究院北京 102629 
刘莎 首都医科大学基础医学院北京 100069 
叶强 中国食品药品检定研究院北京 102629 
陈晨 中国医学科学院医学生物学研究所昆明 650118 
黄洋 中国食品药品检定研究院北京 102629 
王劲松 中国食品药品检定研究院北京 102629 
姜晶钰 中国食品药品检定研究院北京 102629 
牛群 中国食品药品检定研究院北京 102629 
史宇辰 中国食品药品检定研究院北京 102629 
徐潇 中国食品药品检定研究院北京 102629 
陈国庆 中国食品药品检定研究院北京 102629 
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中文摘要:
      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。
英文摘要:
      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 highgradepathogenic microbiology laboratories as scientifi c and technological support and industrial achievementstransformation, as to explain the broad application prospects of high-grade pathogenic microorganism laboratoriesin 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 microbiologicallaboratories in the research and development and evaluation of diagnostic reagents, vaccines and therapeutic drugswas sorted out and the methods of advancing the development of pharmaceutical industry and strengthening thecapacity building of high-level laboratories were expounded. Results and Conclusion: We should give full playto the infrastructure role of high-level pathogenic microorganism laboratories in the field of biomedicine, andadvance the layout of prospective technical reserves for the detection, identifi cation, prevention and control, anddrug treatment of emerging infectious disease pathogens in China. This is an important guarantee for tacklingmajor 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 biosecurityrisks and strengthen national security. Therefore, high-level pathogenic microorganism laboratories have broadapplication prospects in the fi eld of biomedicine.
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