Stability of mRNA and Lipid Nanoparticels Sored in Single-Use Bags

RNA therapy holds immense promise in revolutionizing the treatment landscape for various diseases. For more effective delivery of mRNA to cells, mRNA isencapsulated in lipid nanoparticles (LNPs). During the manufacturing process, mRNA and LNPs need to be stored in storage bags in an ultra-low freezer. In thispresentation, we studied the stability of mRNA and mRNA-encapsulated LNPs stored in single-use bags. 

We prepared LNPs using our lab-made microfluidics mixingdevice, which enables us to prepare LNPs at a rate as fast as 120 mL/min. We report that mRNA-loaded LNPs were stable for at least 6 months at -80°C in Flexboy^®bags and that in vitro transfection activity was confirmed using the Incucyte^® AI Cell Health Analysis Software Module. We also found that the count rate fordynamic light scattering (DLS) dropped within the first hour of storage, suggesting potential particle adsorption to the storage container. The stability of mRNA andmRNA-encapsulated liposomes (in vivo-jetRNA^®+) was also reported.