Althought mRNA vaccines have been developed for nearly 30 years, but due to certain technical bottlenecks in production, stability, and reactivity, the development of mRNA vaccines has been relatively slow. During 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 mRNA vaccine products for preventing infectious diseases in China.
SUN Wei, TONG Yue, YANG Ya-li, WANG Yi-ping, YANG Zhen
. Analysis of critical quality attributes about quality control of mRNA vaccines for the prevention of infectious diseases[J]. Chinese Journal of Pharmaceutical Analysis, 2024
, 44(5)
: 912
-915
.
DOI: 10.16155/j.0254-1793.2024.05.20
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