Accelerated Modular Process Development (AMPD) For Domestic Manufacturing Of Critical Active Pharmaceutical Ingredient Chemical Precursors
Executive Summary
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.