mRNA疫苗起始材料、原辅料和原液技术评估要点的研究与分析

Research and analysis on the points of technical evaluation of starting and raw materials,excipients and stock solution of mRNA vaccines

基于mRNA疫苗生产技术特点,对照新近发布的《WHO预防传染病mRNA疫苗质量、安全及有效性评价法规考虑》,梳理评估现阶段预防传染病mRNA疫苗起始材料、原辅料和原液质量控制具体考虑要点,为我国预防传染病mRNA疫苗的研究和质控提供参考。

Based on the technical characteristics of mRNA vaccines production,the specific points for consideration of quality control of starting and raw materials,excipients and stock solution of mRNA vaccines for the prevention of infectious diseases at the present stage are sorted out and evaluated,comparison of newly released‘WHO Regulatory Considerations for the Evaluation of the Quality,Safety and Efficacy of Messenger RNA Vaccines for the Prevention of Infectious Diseases’.These will provide references for the research and quality control of mRNA vaccines for the prevention of infectious diseasesin China.