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
孙巍 1佟乐 1杨亚莉 1王一平 1杨振1
作者信息
- 1. 中国食品药品检定研究院,北京 102629
- 折叠
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.
Abstract
Althought mRNA vaccines have been developed for nearly 30 years,but due to certain technical bottle-necks in production,stability,and reactivity,the development of mRNA vaccines has been relatively slow.Dur-ing 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 mR-NA vaccine products for preventing infectious diseases in China.
关键词
传染病/mRNA/疫苗/WHO/质量控制Key words
infectious diseases/mRNA/vaccine/WHO/quality control引用本文复制引用
出版年
2024
NETL
NSTL
万方数据