Predicting stability of conventional and mRNA-based vaccines
Vaccine Insights 2025; 4(2), 27–39
DOI: 10.18609/vac.2025.005
In recent years, advanced kinetic models applying Arrhenius-based equations successfully predicted stability of biologicals and conventional vaccines during long-term storage under recommended conditions (2–8 °C) but also during unexpected excursions of temperatures during shipments (e.g., cold-chain breaks). Considering the emergence of new products based on mRNA lipid nanoparticle (LNP) technology, we developed kinetic models describing critical quality attributes of mRNA-LNPs, to predict their stability behavior during storage under isothermal and non-isothermal conditions. Then, realistic storage conditions were applied to predict the shelf life of the products when stored in frozen and liquid states. In addition to predicting the long-term stability of vaccines, the evaluation of temperature variations and their impact on shelf life was presented by means of real-time monitoring of temperature fluctuations during their storage and shipment. Finally, the application of kinetic models was proposed for accurate estimation of internal release limits of products.