National Medical Products Administration Key Laboratory for Quality Research and Evaluation of Biological Products, Institute of Biological Products, National Institutes for Food and Drug Control, Beijing 102600, China.
National Health Commission Key Laboratory of Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing 102600, China.
Viruses. 2023 Mar 2;15(3):668. doi: 10.3390/v15030668.
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.
与其他疫苗相比，信使 RNA（mRNA）疫苗的固有特性及其与脂质纳米颗粒的相互作用，使它们在整个生命周期中都相当不稳定，从而影响其有效性和全球可及性。提高 mRNA 疫苗的稳定性并研究影响稳定性的因素至关重要。由于 mRNA 结构、赋形剂、脂质纳米颗粒（LNP）传递系统和制造工艺是影响 mRNA 疫苗稳定性的主要因素，因此优化 mRNA 结构和筛选赋形剂可以有效地提高 mRNA 疫苗的稳定性。此外，改进制造工艺还可以制备具有安全性和疗效的热稳定 mRNA 疫苗。在这里，我们回顾了与 mRNA 疫苗稳定性相关的监管指导意见，总结了影响 mRNA 疫苗稳定性的关键因素，并提出了提高 mRNA 疫苗稳定性的可能研究途径。
