SBIR Phase II: Continuous, Scalable Crystallizer for Pharmaceutical Manufacturing

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project is to improve a key step used in the >$500-billion market of pharmaceutical manufacturing: purification of active pharmaceutical ingredients (APIs). 90% of all APIs are purified using crystallization, however, the current, mainly batch-based, approaches available have drawbacks from both the commercial and scientific points of view. Current 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 Scalable Continuous Crystallizer technology proposed here, the company 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. In summary, the commercialization of this technology may increase the adoption of advanced technologies, reduce national security risks, and cut the overall costs of pharmaceutical manufacturing. This SBIR Phase II project proposes to further the development of an innovative continuous crystallization device that is expected to be scalable, provide adequate and effective movement of solids, and provide high-quality crystal 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. The company’s patent-pending Scalable Continuous Crystallizer technology uses a combination of several innovative and proprietary features to provide a new technological approach to address transport, uniformity, consistency, reproducibility, and cost challenges. Phase II is focused on scaling up the technology from lab scale to commercial scale. The twin R&D goals are to demonstrate excellent operational crystallizer performance and scalability for multiple model pharmaceutical active ingredients. 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.