Production of Drug Substances and Drug Products at Commercial Scale

An important strategic goal of the Administration for Strategic Preparedness and Response (ASPR) Industrial Base Management and Supply Chain (IBMSC) Office Advanced Manufacturing Domain is to support and facilitate development of the technological infrastructure within the Domestic pharmaceutical manufacturing industry to provide new materials, products, capabilities, and manufacturing paradigms for the Nation. Specifically, ASPR IBMSC is seeking to develop a drug substance and drug product manufacturing design-build-test cycle at a scale that demonstrates the ability to produce hundreds of millions of doses of drug substances to support the American public (population scale), with a focus of sustaining domestic production capacities. This objective will support ASPR IBMSC’s broader long-term goal of commercializing infrastructure that will be accessible to a broad community of users for the purpose of producing drug substances and drug products, creating a new manufacturing paradigm that can be competitive in the domestic and global market, with the added benefit of onshoring drug production. The objective of this project is to commercialize production for at least one (1) drug substance(s) at population scale.