创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

张辉, 刘建阳, 毛群颖, 梁争论, 徐苗. mRNA疫苗质量控制进展[J]. 药学进展, 2022, 46(10): 745-750. DOI: 10.20053/j.issn1001-5094.2022.10.004
引用本文: 张辉, 刘建阳, 毛群颖, 梁争论, 徐苗. mRNA疫苗质量控制进展[J]. 药学进展, 2022, 46(10): 745-750. DOI: 10.20053/j.issn1001-5094.2022.10.004
ZHANG Hui, LIU Jianyang, MAO Qunying, LIANG Zhenglun, XU Miao. Advances in Quality Control of mRNA Vaccine[J]. Progress in Pharmaceutical Sciences, 2022, 46(10): 745-750. DOI: 10.20053/j.issn1001-5094.2022.10.004
Citation: ZHANG Hui, LIU Jianyang, MAO Qunying, LIANG Zhenglun, XU Miao. Advances in Quality Control of mRNA Vaccine[J]. Progress in Pharmaceutical Sciences, 2022, 46(10): 745-750. DOI: 10.20053/j.issn1001-5094.2022.10.004

mRNA疫苗质量控制进展

Advances in Quality Control of mRNA Vaccine

  • 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mRNA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mRNA疫苗质量控制提供参考。

     

    Abstract: 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.

     

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