SBIR Phase I:Continuous Manufacturing for Nucleic Acid Lipid Nanoparticles to Improve the Supply Chain of Therapeutics and Vaccines (COVID-19)

The broader impact /commercial potential of this Small Business Innovation Research (SBIR) Phase I project addresses the need for advanced manufacturing technology that can produce future therapeutics and vaccines. Future clinical treatments will rely on continuous manufacturing to meet demand, both with respect to volume and drug product personalization. This project will incorporate continuous manufacturing principles and process analytical sensors and technology. These processes will enable faster responses to global health crises, such as the COVID-19 pandemic.This Small Business Innovation Research (SBIR) Phase I project will develop a compact, end-to-end, advanced manufacturing system for nucleic acid lipid nanoparticles.This new system will follow current Good Manufacturing Practice (cGMP) and will support end-to-end manufacturing by connecting to a nucleic acid assembly system and a fill-finish system to produce injectable-ready materials. One major goal of this research is to advance the understanding of nanoparticle drug delivery to enable manufacturing injectable ready materials on demand and on-site.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.