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

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.