SBIR Phase I: Continuous, Scalable Crystallizer for Pharmaceutical Manufacturing

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to improve a key step used in the >$500-billion market of pharmaceutical manufacturing: purification of active pharmaceutical ingredients. Ninety percent of all active pharmaceutical ingredients are purified using crystallization, however, current approaches to crystallization have drawbacks from both the commercial and scientific points of view. These techniques are difficult to scale up, are expensive to maintain and manufacture, and are plagued by inconsistency and lack of uniformity in conditions and results. With the development and commercialization of the technology proposed here, this team will address the scalability, cost, and inconsistency issues in order to: 1) speed up the transition to advanced manufacturing approaches (continuous manufacturing), 2) facilitate the re-shoring of drug manufacturing, contributing to addressing the national security challenge of American dependence on foreign drug manufacturers, and 3) reduce drug production costs, which will eventually lead to cheaper drugs for the benefit of the entire population. This SBIR Phase I project proposes to develop an innovative, continuous crystallization device that is scalable, provides adequate and effective movement of solids, and provides high-quality crystalline products, thus fulfilling an unmet need in the pharmaceutical market and in the technical community. The novel design aims to solve the problem of moving solids (crystals) effectively while providing well-controlled flow characteristics with an approach that is scalable from lab to production. This technology uses a combination of several original features to provide a new technological approach to address these transport challenges. This team will first provide a demonstration of the ability to transport slurries with plug flow characteristics. Then, the team will demonstrate the crystallization of a pharmaceutical, benchmarking it against standard batch crystallization methods. Once the technology has been shown to function well in these conditions, the device will be scaled up, in order to be tested and used at production scale. Once complete, the commercialized device is expected to be able to overcome problems with other technologies, including issues of transport, uniformity, consistency, reproducibility, and cost, making this novel device a key player in the future of 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.