SBIR Phase I: On-demand Continuous and Sterile Manufacturing of Injectable Drug Delivery Systems at Industrial Scale on a Portable Microfluidic Chip

SBIR 第一阶段：在便携式微流控芯片上以工业规模按需连续、无菌制造注射给药系统

• 批准号: 2111954
• 负责人: Sagar Prasad Yadavali
• 金额: $ 25.6万
• 依托单位: INFINIFLUIDICS, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2022-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2111954&HistoricalAwards=false
• 关键词: SBIR; Phase; demand; Continuous; Sterile

The broader impact /commercial potential of this Small Business Innovation Research (SBIR) Phase I project will be the promotion of injectable drug delivery systems (iDDS) that will lead to the acceleration of medicine from lab to clinics, reductions in production costs, and the ability for generic manufacturers to produce complex sterile injectable drugs seamlessly. The U.S. faces constant drug shortages, placing patients in danger of treatment delays. Such shortages are often due to issues in manufacturing, requiring new strategies to meet the future needs of patients and pharmaceutical industries. The solution is to develop manufacturing technologies that can generate iDDS on demand to fulfill dynamic market needs. Technologies that can develop particle-based drug delivery formulations will advance the capabilities to treat diseases such as cancer, cardiovascular disease, and other ailments. Such drug platforms have less competition and a higher market potential compared to traditional dosing methods, and with the global market for iDDS estimated to be over $300 billion, this market segment has high potential for such drug manufacturing efforts. This Small Business Innovation Research (SBIR) Phase I project will generate a portable, scalable, reproducible, plug and play ready platform for on-demand generation of iDDS. The key objectives of this research are: 1) Develop robust design and process parameters of an individual microfluidic unit to integrate on chip with VLSDI technology, 2) Validate the compatibility of FDA approved solvents for human use with VLSDI technology to generate injectable drug delivery systems (iDDS), 3) To develop standardized processes to robustly operate the VLSDI chip with 100% reproducibility, re-usability and robustness with precise control over product attributes. By combining microfluidics with semiconductor technology on a chip platform, the proposed innovation would allow for 10,000 microfluidic units per chip, which can be used to increase production of multiple lifesaving drugs. If successful, this technology would increase economic efficiency and productivity at individual and organizational levels in pharmaceutical manufacturing.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.

这项小型企业创新研究（SBIR）I期项目的更广泛的影响 /商业潜力将是促进可注射药物输送系统（IDDS）的促进，这将导致从实验室到诊所的医学加速，生产成本的降低以及通用制造商的能力，使通用制造商能够生产出复杂的无菌无菌注射药物。美国面临持续的药物短缺，使患者处于治疗延迟的危险之中。这样的短缺通常是由于制造业中的问题，需要新的策略来满足患者和制药行业的未来需求。解决方案是开发可以按需生成IDD以满足动态市场需求的制造技术。可以开发基于粒子药物的药物配方的技术将提高治疗癌症，心血管疾病和其他疾病等疾病的能力。与传统的剂量方法相比，这种药物平台的竞争较小，市场潜力较高，而且由于IDD的全球市场估计超过3000亿美元，因此该市场领域对这种药物制造工作具有很高的潜力。这项小型企业创新研究（SBIR）I阶段项目将生成一种便携式，可扩展，可重现的，插头和播放现成的平台，用于按需生成IDD。 The key objectives of this research are: 1) Develop robust design and process parameters of an individual microfluidic unit to integrate on chip with VLSDI technology, 2) Validate the compatibility of FDA approved solvents for human use with VLSDI technology to generate injectable drug delivery systems (iDDS), 3) To develop standardized processes to robustly operate the VLSDI chip with 100% reproducibility,可重复使用和鲁棒性，并精确控制产品属性。通过在芯片平台上将微流体与半导体技术相结合，拟议的创新将允许每个芯片10,000个微流体单元，可用于增加多种救生药物的生产。如果成功，这项技术将提高药品制造业的个人和组织水平的经济效率和生产率。该奖项反映了NSF的法定任务，并且使用基金会的知识分子优点和更广泛的影响评估标准，认为值得通过评估来获得支持。