Executive Summary
Using RAPID’s well-proven approach to setting and tracking project tasks and milestones, the team will create and test a standardized framework and modular processing testbed/Center Of Excellence (COE) for accelerated development of processes to manufacture active pharmaceutical ingredients (API) specialty chemical precursors.
The project will immediately impact coronavirus response through creation and testing of a new accelerated methodology and modular processing COE for development of processes to manufacture API specialty chemical precursors. Tools and capabilities such as this do not currently exist in the U.S. for general use. The process development framework and national asset testbed capabilities will be made available to RAPID’s members and disseminated broadly to AIChE’s Process Development Division and Pharmaceutical Discovery, Development and Manufacturing Forum (PD2M). The team envisions that the COE will also serve as a tool to develop processes and build production capacity for on-shoring of selected specialty chemicals, API precursors, and APIs, and the COE/MATRIC (now called AVN) may serve as a production center for future coronavirus response scenarios.
The project team interviewed process development experts and learned that the current “best practice” process development work process is essentially the same for modular and non-modular processing. Many of the interviewed experts expressed frustration that modular processing has not reduced the time to market/profit. To address this concern, the project team developed and proposed a framework based on the Damkohler number (Da) for generating and screening multiple options before selecting and detailing one. The team also defined equipment infrastructure for a modular testbed, built modular pilot plant systems, and demonstrated the pilot systems for production of an exemplary active pharmaceutical ingredient precursor relevant to coronavirus response efforts.