The coronavirus pandemic highlights the need to make new medical countermeasures available on a large scale much more quickly than ever before. The development of medical countermeasures requires rapid, coordinated innovation across diverse scientific, regulatory, and manufacturing domains. Current approaches often operate in silos, leading to inefficiencies, late-stage failures, and limited adaptability during public health emergencies.
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 test bed. 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 test bed 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.
Physical demonstration of intensified processing that uses currently available technology now and adapts to keep on the cutting edge in the future.
Interactions among companies and stakeholders will create shared understanding that will positively impact our domestic manufacturing capabilities for medical countermeasures and vaccines in response to any future coronavirus pandemic.
The NIIMBL End-to-End Test Bed offers the biopharmaceutical industry a collaborative, risk-mitigated platform to accelerate the adoption of advanced, integrated, and continuous biomanufacturing technologies. By enabling rapid prototyping, process intensification, and data-driven optimization in a controlled environment, the test bed reduces costs, enhances flexibility, and strengthens supply chain resilience—ultimately ensuring faster, scalable production of critical therapeutics during routine operations and public health emergencies.
Comprehensive infrastructure modifications including utility enhancements and installation of state-of-the-art analytical equipment in the End-to-End Test Bed at NIIMBL headquarters.
Lee, K., Conference Participant, ARP-30 – Enhancement of the End-to-End Manufacturing Testbed for Fast, Flexible Drug Substance Manufacturing, NIIMBL National Meeting, Washington, D.C., June 26, 2025.
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