Continuous, Scalable, Safe Hydrogenation for Pharmaceutical Manufacturing

About This Grant

Project Summary/Abstract Domestic pharmaceutical manufacturing is currently struggling to meet growing demands. To address this challenge, it is crucial to develop tools that can significantly enhance the productivity of existing production facilities. Pharmaceutical production today relies heavily on batch-based chemical synthesis, where chemical reactions occur in several separate steps within large reactors. Among these steps, hydrogenation stands out as a very frequent and important chemical transformation unfortunately plagued by significant technical challenges, including scalability issues and safety risks due to the explosive nature of hydrogen. Additionally, the process requires expensive precious metal catalysts, further complicating production. We propose the development of a safe, scalable, and continuous hydrogenation solution for pharmaceutical applications. This innovative approach will combine W.L. Gore’s advanced catalyst immobilization technique with a layered modular reactor design designed by Zaiput. Our goal is to overcome the current challenges associated with hydrogenation, such as safety concerns, scalability limitations, and the inefficiencies inherent in traditional batch-based chemical synthesis. In Phase I of this SBIR project, we will focus on key technological innovations necessary to demonstrate the scalability of the layered reactor concept. Specifically, we will: 1) develop an advanced gas-liquid distribution module that ensures uniform distribution across various reactor sizes, and 2) demonstrate the system’s effectiveness by achieving scalable reaction results. In Phase II, we will design and build larger-scale devices, conduct real-world testing in partnership with pharmaceutical manufacturers to validate the technology in a manufacturing setting, and initiate the commercialization process. If successful, this project will produce a tool capable of immediately addressing hydrogenation challenges and contribute to the reshoring of pharmaceutical manufacturing to the U.S. This aligns with government priorities by offering safer, more efficient, cost-effective, and environmentally friendly hydrogenation processes.