Single-use bags as a viable solution for long-term stability of lipid nanoparticles

Therapeutics based on ribonucleic acid (RNA), particularly messenger RNA (mRNA) therapies, are transforming the treatment landscape for various diseases, including infectious diseases and cancer. A key challenge in the widespread adoption of these therapies is ensuring the long-term stability of mRNA and lipid nanoparticles (LNPs), which are essential for effective delivery. In this study, we examined the long-term stability of mRNA and mRNA-encapsulated LNPs stored in single-use (SU) bags, a cost-effective and scalable solution for pharmaceutical storage. Our findings demonstrate that mRNA-loaded LNPs remained stable and functional for six months when stored at −80 °C in SU bags, with no significant changes in particle size or RNA concentration. The in vitro transfection efficiency also remained consistent after storage. Additionally, we report the long-term stability of mRNA in SU bags at −80 °C and the short-term stability of mRNA-encapsulated liposomes stored at 4 °C for two weeks in SU bags. However, a decrease in particle concentration was observed within the first hour of storage, suggesting particle adsorption to the storage container. We investigated the potential causes of adsorption and identified the impact of a smooth LNP production procedure and the integrity of the LNP structure on particle adsorption and aggregation. These findings indicate that SU bags are a viable option for the long-term storage of LNPs and mRNA, providing valuable insights for the bioprocessing and manufacturing of genetic medicines.