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

SBIR 第一阶段：连续生产核酸脂质纳米粒子，以改善治疗药物和疫苗的供应链 (COVID-19)

• 批准号: 2151477
• 负责人: Antonio Costa
• 金额: $ 25.6万
• 依托单位: DIANT PHARMA INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-15 至 2023-03-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2151477&HistoricalAwards=false
• 关键词: SBIR; Phase; Continuous; Manufacturing; Nucleic

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.

这一小型企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力满足了对能够生产未来疗法和疫苗的先进制造技术的需求。未来的临床治疗将依赖于持续生产来满足需求，无论是在数量方面还是药物产品个性化方面。该项目将结合连续制造原理和工艺分析传感器和技术。这些过程将使人们能够更快地对全球健康危机做出反应，例如新冠肺炎疫情。这个小企业创新研究(SBIR)第一阶段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。这一新系统将遵循当前的良好制造规范(CGMP)，并将通过连接到核酸组装系统和填充-整理系统来支持端到端的制造，以生产可注射的材料。这项研究的一个主要目标是促进对纳米药物输送的理解，以便能够按需和现场制造可注射即用材料。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。