Request for Project Proposals: Production of Drug Substances and Drug Products at Commercial Scale: Anti-Microbials and Large Volume Parenterals

This opportunity focuses on developing at least one key starting material, drug substance, and/or drug product identified on the FDA’s List of Essential Medicines. Preference will be given to proposals focused on anti-microbials and large volume parenterals.

Submissions Due: Mar. 16 at 1 p.m. ET

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Draft SOO Feedback Survey: Advanced Research and Development of Medical Countermeasures Through Agile and Distributed End-to-End Drug Manufacturing

The primary objective of this project is to develop and commercialize manufacturing capabilities that allow for end-to-end production of drug substances and drug products under cGMP and subsequent regulatory filing that enables broad commercial adoption and sale of domestically produced drug substances and drug products to meet US demands for medical countermeasures.

Responses Due: Mar. 17 at 11:59 p.m. ET

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Draft SOO Feedback: VMI as a Service for APIs & FDF Drug Products

This project aims to establish Vendor Managed Inventory (VMI) as a scalable service model to enhance the US Government’s ability to operationalize a strategic API reserve at population scale. Core capabilities include procurement, testing and retesting, cGMP-compliant storage, real-time inventory management, rapid API-to-FDF conversion, and coordinated distribution to more than 2,000 health systems and distribution centers nationwide.

Responses Due: Mar. 17 at 11:59 p.m. ET

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Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium)

Strengthening and enhancing domestic biopharmaceutical manufacturing capabilities

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Partnership Opportunities

Seeking partnerships to rapidly respond to future Public Health Emergencies (PHE)

Apply to Join the BioMaP-Consortium

No Cost Barrier for Entry

Pre-negotiated Terms

Fast & Flexible Partnerships

Networking & Engagement with Industry

Industrial Base Expansion of Supply Chain

Engage with the network of organizations and personnel that provide all goods and services in support of the entire biomanufacturing process, to include, but not limited to, raw materials, consumables, and fill-finish services.

Biomanufacturing Capacity Expansion and Reservation

Prepare and provide timely, integrated, and sufficient medical countermeasures in response to emerging pathogens with pandemic potential through establishing, expanding and/or reserving drug substance and/or drug product manufacturing capacities.

Advanced Biomanufacturing Technologies

Address new and emerging technologies, that enhance existing capabilities that increase the speed, quality, safety, yield, efficiency of the biomanufacturing process or the safety, quality, effectiveness, or availability of the resulting biopharmaceutical drug product.