Research Advances on the Stability of mRNA Vaccines

作者：Feiran Cheng, Yi‐Ping Wang, Yu Bai, Zhenglun Liang, Qunying Mao, Dong Liu, Desheng Wu, Miao Xu · 发表于：Viruses · 年份：2023 · DOI：10.3390/v15030668 · 被引用次数：161 · 研究领域：RNA Interference and Gene Delivery、Immunotherapy and Immune Responses、RNA and protein synthesis mechanisms

Compared to other vaccines, the inherent properties of messenger RNA (mRNA) vaccines and their interaction with lipid nanoparticles make them considerably unstable throughout their life cycles, impacting their effectiveness and global accessibility. It is imperative to improve mRNA vaccine stability and investigate the factors influencing stability. Since mRNA structure, excipients, lipid nanoparticle (LNP) delivery systems, and manufacturing processes are the primary factors affecting mRNA vaccine stability, optimizing mRNA structure and screening excipients can effectively improve mRNA vaccine stability. Moreover, improving manufacturing processes could also prepare thermally stable mRNA vaccines with safety and efficacy. Here, we review the regulatory guidance associated with mRNA vaccine stability, summarize key factors affecting mRNA vaccine stability, and propose a possible research path to improve mRNA vaccine stability.