The Enabling Innovations and Technologies Office within the ASPR Center for Industrial Base Manufacturing and Supply Chain strengthens U.S. manufacturing capabilities and takes actions that promote supply chain resilience, so we are better prepared for public health emergencies. The EIT Office advances the development, deployment, and on-shoring of manufacturing capacities for Key Starting Materials, Drug Substances, and Drug Products that enables population-scale fill/finish and agile and distributed cGMP compliant production of pharmaceuticals and supportive care fluids to help strengthen supply chain resilience, grow the bioeconomy, and deploy increasingly agile, renewable and sustainable pharmaceutical resources capable of immediately responding to surges in demand caused by public health emergencies.
EIT leads efforts to commercialize and scale agile and distributed manufacturing of critical drug substances and drug products and to improve access and availability of these supplies.
Population-Scale Fill/Finish
EIT is leveraging Blow-Fill-Seal (BFS) aseptic drug packaging via connectable components to create pre-filled delivery systems at development and commercial scale. EIT is developing novel thermal processes that enable production of temperature-sensitive therapeutics and small molecule drugs within BFS.
Agile and Distributed Drug Substance and Drug Product Manufacturing
EIT is improving the way that we produce and scale drug substance and drug product development by supporting programs related to distributed manufacturing; onshore drug substance and drug product production; and agile manufacturing :
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Distributed Manufacturing of Drug Substances and Drug Products: EIT is developing a rapidly adaptable, scalable, and distributed network of medicine-producing systems comprised of nodes, including drug substance and drug product manufacturing nodes, that complement point-of-care sterile/non-sterile medicine compounding nodes.
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Distributed Manufacturing of IV Fluids: EIT is addressing the need to improve the U.S. pharmaceutical base through scalable and distributed manufacturing and production of IV fluids, starting with 0.9N saline, with potential to expand into other fluids or medications for infusion therapies or dialysis, at the point of need.
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On-Shoring of Drug Substance and Drug Product Production: EIT is onshoring the production of essential medicines to the U.S. This will generate domestic self-sufficiency for manufacturing critical, generic API’s and finished drug products to prevent future shortages with semi-continuous processing and manufacturing.
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Agile Manufacturing: EIT is creating the technology and process model for real-time qualification of finished drug products produced in agile manufacturing platforms. This will establish AI-driven or algorithmic approaches for producing multiple MVP drugs on the same hardware and will support point-of-need manufacturing, addressing the needs of the American public during public health emergencies, and enabling a more resilient pharmaceutical supply chain.
Biologically Derived Substances Manufacturing
EIT is creating a new manufacturing paradigm that can produce at population scale, and onshore drug production in novel ways to be globally competitive. This effort is one of the first efforts to commercialize engineered living systems that make small molecule drug substances for analgesics, clotting agents, anticholinergics and reversal agents using simple inputs. EIT’s performers are accelerating innovation, integrating synthetic biology, AI, and process engineering to re-shore production of critical key starting materials and APIs.
Collaborating to Bolster Innovation
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BioMaP Consortium: In partnership with BARDA and IBMSC, EIT is executing multiple efforts through the BioMaP Consortium. The consortium supports and facilitates development of the technological infrastructure within the domestic US bioengineering industry to provide new materials, products, capabilities, and manufacturing paradigms for the Nation.
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EQUIP-A-Pharma: In collaboration with DARPA, the EQUIP-A-Pharma program aims to develop informatics-based models to create a real-time digital regulatory approval framework for qualification of pharmaceuticals produced in agile pharmaceutical manufacturing platforms.
