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

这项小企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力将是促进注射药物输送系统（iDDS），这将加速药物从实验室到诊所的发展，降低生产成本，并使仿制药制造商能够无缝地生产复杂的无菌注射药物。美国面临持续的药物短缺，使患者面临治疗延误的危险。这种短缺往往是由于制造方面的问题，需要新的战略来满足病人和制药工业未来的需要。解决方案是开发能够按需生成iDDS的制造技术，以满足动态的市场需求。可以开发基于颗粒的药物输送配方的技术将提高治疗癌症、心血管疾病和其他疾病的能力。与传统给药方法相比，这类药物平台的竞争较少，市场潜力更大，而且iDDS的全球市场估计超过3000亿美元，这一细分市场对此类药物制造工作具有很大的潜力。这个小企业创新研究（SBIR）第一阶段项目将为按需生成iDDS生成一个便携、可扩展、可复制、即插即用的平台。本研究的主要目标是：1)开发单个微流体单元的稳健设计和工艺参数，以集成在芯片上的VLSDI技术；2)验证FDA批准的人用溶剂与VLSDI技术的兼容性，以生成注射药物输送系统（iDDS）； 3)开发标准化流程，以稳健地操作VLSDI芯片，具有100%的可重复性、可重用性和鲁棒性，并精确控制产品属性。通过将微流体与半导体技术结合在芯片平台上，提出的创新将允许每个芯片拥有10,000个微流体单元，这可用于增加多种救生药物的生产。如果成功，这项技术将提高制药行业个人和组织层面的经济效率和生产力。该奖项反映了美国国家科学基金会的法定使命，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 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.