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

这个小型企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力解决了对先进制造技术的需求，可以生产未来的治疗药物和疫苗。未来的临床治疗将依赖于连续生产来满足需求，无论是在产量还是药品个性化方面。该项目将结合连续制造原理和过程分析传感器和技术。这一小企业创新研究（SBIR）一期项目将开发一个紧凑的、端到端的先进核酸脂质纳米颗粒制造系统。 该新系统将遵循现行的药品生产质量管理规范（cGMP），并将通过连接核酸组装系统和灌装-成品系统来支持端到端的生产，以生产可注射的材料。该研究的一个主要目标是促进对纳米颗粒药物输送的理解，以实现按需和现场制造可注射的现成材料。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.