SBIR Phase II: 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 II project is to enable the availability of a revolutionary manufacturing process for pharmaceuticals. The project consists of the development of novel process technologies, as well as the integration of these processes into an end-to-end continuous manufacturing line that can produce drugs continuously (24/7 basis). This 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%, projected costs reduced by 50%, while improving product quality. The impact on society will be considerable: patients will receive better quality drugs; 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 developed). Finally, it will be possible to relocate manufacturing plants and jobs back in the U.S. (more efficient processes = lower costs). The proposed project builds upon a successful Phase I SBIR project, as well as five years of collaboration between a premier research institution and a leading pharmaceutical company aimed at developing a novel continuous manufacturing process to overcome the limitations of the current standard, batch manufacturing. The first objective of this NSF project is to further develop two novel elements of a multistep, continuous manufacturing process (i.e. heterogeneous crystallization and electrospinning for solid dosage forms), so they run reliably under different operating conditions. This is important because commercial production requires that they perform consistently and reliably 24/7. Thus, these novel unit operations will be studied under different operating conditions and starting materials, while their design is 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 second objective is to integrate these two units into a broader end-to-end continuous manufacturing process capable of producing high-quality pharmaceuticals on a continuous basis. The integrated process will also feature three unit operations on separation, filtration and drying that were developed during Phase I of this SBIR project.