Production of Drug Substances and Drug Products at Commercial Scale
BioMaP-Consortium RPP-24-02-KSM-API supports a strategic goal of ASPR IBMSC, which seeks 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. The objective is to commercialize production for at least one (1) drug substance(s) at population scale.
Forging a Resilient Future in Health Security
Project Details
Member Organization: API Innovation Center
Award Date: 9/11/2024
Award Ceiling: $13,968,691
Project Duration: 24 Months
Solicitation Number: RPP-24-02-KSM-API
Project Objective: The API Innovation Center (APIIC) will lead the development and domestic production of three critical active pharmaceutical ingredients (APIs) used in the treatment of asthma, diabetes, and anxiety disorders. APIIC will leverage advanced manufacturing technologies and cutting-edge research to further national strength in pharmaceutical innovation and supply chain resilience.
Platform Technologies for Scalable Manufacturing of APIs Drugs
Project Details
Member Organization: Resilience Government Services
Award Date: 9/30/2024
Award Ceiling: $17,496,354
Project Duration: 24 Months
Solicitation Number: RPP-24-02-KSM-API
Project Objective: Resilience will leverage its current Good Manufacturing Process (cGMP) manufacturing infrastructure, analytical development expertise, and regulatory and quality experience to fortify the pharmaceutical supply chain and enhance production of the nation’s critical medicines. Through this project, Resilience and their partner will streamline production processes for active pharmaceutical ingredients made within the United States, including submitting the necessary data to the U. S. Food and Drug Administration for Resilience to become an approved domestic Active Pharmaceutical Ingredient (API) supplier for pharmaceutical manufacturers.
