SBIR Phase I: Novel pharmaceutical manufacturing technologies to deliver more affordable medications to patients faster and with better quality

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is that it will enable the commercialization of a groundbreaking manufacturing process for pharmaceuticals. The project consists of the development of novel process technologies to manufacture drugs on a continuous basis (24 hours a day, 365 days a year), which is different from the current methodology that produces large quantities of drugs at discrete time points (e.g. large batch quantities are produced several times a year). A working pilot plant of this process demonstrated significant operational advantages with a marketed drug ? production time was reduced from 200 days to 2 days, plant footprint decreased by 90%, costs reduced by 50%, while improving product quality. The impact on society will be considerable ? patients will receive better quality drugs; the risk of drug shortages will be greatly reduced; and pharmaceutical companies will be able to manufacture and distribute their drugs in a much more cost-effective and efficient manner, allowing them to reallocate more capital to Research and Development (new drugs can be developed). Finally, it will be possible to relocate manufacturing plants and jobs back in the U.S., as this manufacturing process will produce drugs very cheaply. The proposed project builds upon five years of collaboration between a premier research institution and a leading pharmaceutical company aimed at developing a novel manufacturing process for pharmaceuticals that will overcome the limitations of the current standard, or batch manufacturing process. The joint endeavor was successful; however, the novel process was built in a university laboratory setting, and is not ready for commercial implementation. The objective of this NSF project is to further develop three novel elements, or unit operations of this multistep manufacturing process (i.e. a membrane separator, a rotary filter and a drum dryer), so they are robust and able to run under different operating conditions. This is important because commercial production requires that they perform consistently and reliably on a continuous basis. Thus, these novel unit operations will be studied under different operating conditions and starting materials, while their design and compositions are optimized. Success will be defined when the unit operations achieve: 1) maximal operational efficiency, 2) industry standard manufacturing capabilities, and 3) qualification to be used across the Research and Development manufacturing spectrum. The end goal is to incorporate these three critical unit operations into an integrated manufacturing process capable of producing high-quality pharmaceuticals on a continuous basis.