摘要
mRNA疫苗具有研发和生产周期短、易大规模生产的特点,但作为一类全新的疫苗,其质量控制仍缺少系统的质量研究数据和经验。通过梳理m RNA疫苗质控相关指南文件和文献,总结归纳疫苗质控项目和标准、检测方法以及标准物质等质控要点,旨在为m RNA疫苗质量控制提供参考。
mRNA vaccines are characterized by rapid research and development,short production cycle and easy large-scale production.However,as a new type of vaccines,there is still a lack of systematic study data and experience in their quality control.This article reviews the guidance documents and literature related to the quality control of mRNA vaccines,and summarizes the key considerations in product quality control items and acceptance criteria,detection methods and standards,aiming to provide reference for the quality control of mRNA vaccines.
作者
张辉
刘建阳
毛群颖
梁争论
徐苗
ZHANG Hui;LIU Jianyang;MAO Qunying;LIANG Zhenglun;XU Miao(National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《药学进展》
CAS
2022年第10期745-750,共6页
Progress in Pharmaceutical Sciences
基金
中国医学科学院医学与健康科技创新工程项目(No.2021-I2M-5-005)。
