Enhancement of the End-to-End Manufacturing Testbed for Fast, Flexible Drug Substance Manufacturing

The coronavirus pandemic highlights the need to make new medical countermeasures available on a large scale much more quickly than ever before. NIIMBL, through its major member biopharmaceutical manufacturing companies, has established a vision that there is a significant opportunity to transform CMC (chemistry, manufacturing, and controls) development and manufacturing through end-to-end integration and technology advancement. A NIIMBL-led program has already been initiated in this area, and the work has been accelerated to a degree with the investment made through the CARES Act which enabled NIIMBL to move faster toward the procurement of assets needed to establish the testbed. We will further accelerate the effort, and increase the industrial relevance, of this Process Intensification (PI) Testbed Workstream using American Rescue Plan investment to help the program realize benefits faster. The testbed will use state-of-the-art technology for process equipment, sensors and control, and it will be flexible so that new unit operations, sensors and controls can be tested using a standard process.