Khan M D Faizul Hussain, Baudin Floriane, Sudalaiyadum Perumal Ayyappasamy, Kamen Amine A
Viral Vectors and Vaccines Bioprocessing Group, Department of Bioengineering, McGill University, Montreal, QC H2X 1Y4, Canada.
Department of Bioengineering, McGill University, Montreal, QC H3A 0E9, Canada.
Vaccines (Basel). 2025 Aug 12;13(8):853. doi: 10.3390/vaccines13080853.
The instability of mRNA vaccines presents significant challenges for their storage, transportation, and large-scale distribution, particularly in resource-limited countries. Recently, freeze-drying (lyophilization) has been considered as a promising approach for preserving mRNA vaccine efficacy. This formulation technique enhances the long-term stability of mRNA vaccines by converting them into a stable dry powder. The purpose of this review is to provide an overview of the current knowledge on the progress of freeze-drying techniques for mRNA vaccines, with emphasis on the associated challenges. This review highlights the factors influencing the stability of freeze-dried mRNA vaccines and provides a comprehensive overview of the formulation components, including excipients, buffers, and surfactants, as well as the process parameters and storage conditions that aim to improve stability and shelf-life. By providing these insights, this review supports the advancement of more robust, scalable, and efficient lyophilization protocols, ultimately addressing the stability limitations of mRNA vaccines and enhancing their global accessibility.
mRNA疫苗的不稳定性给其储存、运输和大规模分发带来了重大挑战，尤其是在资源有限的国家。最近，冷冻干燥（冻干）被认为是一种保存mRNA疫苗效力的有前景的方法。这种制剂技术通过将mRNA疫苗转化为稳定的干粉来提高其长期稳定性。本综述的目的是概述目前关于mRNA疫苗冷冻干燥技术进展的知识，重点关注相关挑战。本综述强调了影响冻干mRNA疫苗稳定性的因素，并全面概述了制剂成分，包括赋形剂、缓冲剂和表面活性剂，以及旨在提高稳定性和保质期的工艺参数和储存条件。通过提供这些见解，本综述支持更强大、可扩展和高效的冻干方案的推进，最终解决mRNA疫苗的稳定性限制并提高其全球可及性。
