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

这个小型企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力将是促进可注射药物递送系统（iDDS），这将导致药物从实验室到诊所的加速，降低生产成本，以及仿制药制造商无缝生产复杂无菌注射药物的能力。美国面临持续的药物短缺，使患者面临治疗延误的危险。这种短缺通常是由于制造业的问题，需要新的战略来满足患者和制药行业的未来需求。解决方案是开发能够按需生成iDDS的制造技术，以满足不断变化的市场需求。能够开发基于颗粒的药物递送制剂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。与传统给药方法相比，此类药物平台的竞争较少，市场潜力更大，全球iDDS市场估计超过3000亿美元，这一细分市场对此类药物制造工作具有很高的潜力。这个小型企业创新研究（SBIR）第一阶段项目将产生一个便携式，可扩展的，可复制的，即插即用的平台，按需生成iDDS。这项研究的主要目标是：1）开发单个微流体单元的稳健设计和工艺参数，以在芯片上与VLSDI技术集成，2）验证FDA批准的用于人类使用的溶剂与VLSDI技术的相容性，以产生可注射药物递送系统（iDDS），3）开发标准化工艺，以100%再现性稳健地操作VLSDI芯片，可重复使用性和鲁棒性，对产品属性进行精确控制。通过在芯片平台上将微流体技术与半导体技术相结合，拟议的创新将允许每个芯片有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，这项技术将提高个人和组织层面的经济效率和生产力在制药manufacturing.This奖项反映了NSF的法定使命，并已被认为是值得的支持，通过评估使用基金会的知识价值和更广泛的影响审查标准。

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.