预防传染病mRNA疫苗原材料、原液质控要点分析  

Analysis of Important Factors about Quality Control of Raw Materials and Stock Solution 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 Yali;Wang Yiping;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：《中国药事》2024年第2期184-188,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:梳理归纳预防传染病mRNA疫苗原材料和原液质控要点,为我国此类产品质量控制提供参考。方法:通过梳理世界卫生组织及相关标准和审评机构关于预防传染病mRNA疫苗原材料、原液质控指导文件,以及相关监管指南和文献,总结归纳预防传染病mRNA疫苗原材料和原液关键质量控制属性及相关要求。结果与结论:作为新型生物制品,mRNA疫苗核酸结构和脂质体包裹制剂的特性决定了该类疫苗质控特点,序列和完整性、含量及纯度、加帽率和包封率是mRNA疫苗特有的、决定有效性和安全性的关键质量参数。从原材料和原液制备阶段就建立多个与mRNA特性相关的质控要点及其检测方法,将有助于保障预防传染病mRNA疫苗安全有效、质量可控。Objective:To provide references for the quality control of such products in China by combing and summarizing the key points of quality control of raw materials and stock solution of mRNA vaccines for preventing infectious diseases.Methods:By combing the World Health Organization(WHO)and relevant standards and review agencies on the quality control guidance documents for raw materials and stock solution of mRNA vaccine for prevention of infectious diseases,and related regulatory guidelines and literature,the key quality control attributes and related requirements of raw materials and stock solution of mRNA vaccines for the prevention of infectious diseases were summarized.Results and Conclusion:As a new biological product,the nucleic acid structure of mRNA vaccines and the characteristics of liposome encapsulated preparations determined the quality control characteristics of this vaccine.Sequence and integrity,quantity and purity,percentage capping and percentage encapsulation were the key quality parameters unique to mRNA vaccines,which determined effi cacy and safety.Establishing multiple quality control points and detection methods related to mRNA characteristics from the preparation stage of raw materials and stock solution will help ensure the safety,eff ectiveness,and controllable quality of mRNA vaccines for preventing infectious diseases.

关 键 词：预防传染病 mRNA疫苗 世界卫生组织 质量控制 要点分析 

分 类 号：R95[医药卫生—药学]