(571r) Stability of mRNA and Lipid Nanoparticles Stored in Single-Use Bags

RNA therapy holds immense promise in revolutionizing the treatment landscape for various diseases, including cancer, infectious diseases, and genetic disorders. For more effective delivery of mRNA to the cells, typically, mRNA is packaged within lipid nanoparticles (LNPs). During the manufacturing process, mRNA and LNPs need to be stored in storage bags in a refrigerator or ultra-low freezer. In this presentation, we studied the stability of mRNA and mRNA-encapsulated LNP stored in single use bags, specifically, Flexboy® by Sartorius. We looked at adsorption of mRNA and LNP complexes onto the storage bags, which is crucial for ensuring the stability and efficacy of these advanced therapeutics. Adsorption refers to the binding of molecules onto surfaces, and in the case of mRNA-LNP complexes, it can impact their integrity and potency during storage.

We have compared the mRNA and LNP size, PDI and concentration of samples stored in single-use bags versus glass vials. We found that count rate for dynamic light scattering (DLS) dropped within the first hour of storage, suggesting particle adsorption to the storage container. We will report that mRNA-loaded LNP was stable at least 3 months at -80°C in Flexboy bags and that in vitro transfection activity of LNP was confirmed using Incucyte® AI Cell Health Analysis Software Module. We will also discuss about impact of various lipid formulations on adsorption to these bags.