(368d) Improvement of Storage Stability of mRNA Vaccine Using Lipid Based Drug Delivery System

The lipid nanoparticle (LNP) carrier-based mRNA vaccine was first used as the COVID-19 vaccine, proving to be a next-generation vaccine technology beyond the existing vaccine. However, as it is the first mRNA vaccine, problems were also exposed, especially low stability of the mRNA and lipid nanoparticle carriers and need to be stored/transmitted at extremely low temperatures, such as cold-chain issues and mRNA distribution problems in underdeveloped countries. Therefore, the purpose of this study is to develop an efficient and reliable storage system that can solve transportation and storage stability, which has been pointed out as a problem of existing LNPs for mRNA delivery.

In this study, through the low-temperature decompression concentration method and stabilizer, our goal is maintaining more than 90% of the initial efficacy of the mRNA vaccines at low temperature (2 ~ 8 ℃) for more than 3 months. The developed low-temperature decompression concentration method and stabilizing agents enabled made mRNA vaccines more stable in low temperature (2 ~ 8 ℃). Comparative study to existing LNP system and conventional storage protocol was presented to monitor the change of LNP size, distribution, and efficacy data over time. Preservation additives and freeze-drying process was optimized to improve the storage period under refrigerated distribution conditions. mRNA vaccines in good stability will reduce the difficulties caused by the existing transportation and storage problems and reduce the disposal of the vaccines, contributing to the development of vaccines against spread of infectious diseases or cancer cells.