预防传染病mRNA疫苗成品质量控制要点分析  

Analysis of critical quality attributes about quality control of mRNA vaccines for the prevention of infectious diseases

作　　者：孙巍[1] 佟乐[1] 杨亚莉[1] 王一平[1] 杨振[1] SUN Wei;TONG Yue;YANG Ya-li;WANG Yi-ping;YANG Zhen(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《药物分析杂志》2024年第5期912-915,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：mRNA疫苗已经开发近30年,但由于生产环节、稳定性和反应原性存在一定的技术瓶颈,导致mRNA疫苗发展较为缓慢。如今,基于预防COVID-19的mRNA疫苗的应用,充分验证了预防传染病mRNA疫苗的有效性和安全性。本文通过梳理WHO及药品监管和标准化机构关于预防传染病mRNA疫苗成品质控的指导文件,总结归纳预防传染病mRNA疫苗成品关键质量控制属性及相关要求,旨在为中国预防传染病mRNA疫苗质量控制提供参考。Althought mRNA vaccines have been developed for nearly 30 years,but due to certain technical bottlenecks in production,stability,and reactivity,the development of mRNA vaccines has been relatively slow.During the epidemic of COVID-19,mRNA vaccine had been fully verified its effectiveness and safety for preventing infectious diseases.Here,this article summarized the key quality control attributes and related requirements of mRNA vaccine products for preventing infectious diseases by reviewing the quality control guidance documents of WHO and drug regulatory and standardization agencies,aiming to provide reference for the quality control of mRNA vaccine products for preventing infectious diseases in China.

关 键 词：传染病 MRNA 疫苗 WHO 质量控制 

分 类 号：R917[医药卫生—药物分析学]