(562d) Production of Stable, Low Cost mRNA Lipid Nanoparticle (LNP) Powders By Confined Impinging Jet Precipitation and Cold Spray Drying: Stability and Process Design

Lipid Nanoparticles (LNPs) that deliver mRNA and siRNA have dramatically impacted the field of therapeutic drug delivery. Over 3 billion doses of the COVID vaccine produced by Pfizer based on our confined impinging jet (CIJ) technology have been administered to date. A significant limitation of mRNA LNPs has been the need to distribute and hold these LNPs at -40 to -80 C (cold chain distribution). This has limited the ability to distribute these vaccines in global health applications to less developed nations. We present a new approach to produce stable dry powders by scalable and economic processes. The mRNA LNPs are produced by CIJ precipitation and then dry powders are produced by “cold spray drying”. This approach produces dry powders at significantly lower cost than lyophilization and by a process that is scalable. It also eliminates the freezing step, which is a major source of instability in current COVID vaccines that requires high concentrations of lyoprotectants. The fundamentals of each process step will be presented.