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.

View ASPR’s Press Release Here

View API Innovation Center’s Press Release Here

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.

View ASPR’s Press Release Here

View Resilience’s Press Release Here

Advanced Biomanufacturing Processes for Agile Production of Drug Substances

Project Details

Member Organization: Antheia, Inc.
Award Date: 11/25/2024
Award Ceiling: $11,958,014
Project Duration: 24 Months

Solicitation Number: RPP-24-02-KSM-API

Project Objective: Antheia’s cutting-edge biomanufacturing technology offers a domestic solution to mitigate drug shortages, bolstering national security, economic security, and public health. Through this project, Antheia will domestically produce one pharmaceutical ingredient that is critical to public health through to commercial scale.

View ASPR’s Press Release Here

View Antheia’s Press Release Here

Distributed Manufacturing of Natural Product-Based Essential Medicines

Project Details

Member Organization: Manus Bio, Inc.
Award Date: 11/25/2024
Award Ceiling: $32,394,626
Project Duration: 25 Months

Solicitation Number: RPP-24-02-KSM-API

Project Objective: This project will enable Manus to establish key infrastructure to manufacture natural product drugs through biomanufacturing and semi-synthesis, onshore critical medicines manufacturing, and advance the U.S. bioeconomy. To achieve this, Manus and its partner will combining Manus’ bioalternatives scale-up platform for accessing natural products with its partner’s proprietary flow chemistry technology, which will be able to produce these essential medicines at scale.

View ASPR’s Press Release Here

View Manus’ Press Release Here