BARDA BioMaP Seeks Agile, Distributed Drug Manufacturing for Medical Countermeasures

Katie Cunningham, Growth Marketing Manager

Giacomo Apadula, Chief Executive Officer

Updated to reflect Amendment 3, issued on November 5, 2026.

The Biomedical Advanced Research and Development Authority (BARDA) has released has released a Request for Project Proposals through Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP), seeking U.S.-based teams that can develop and commercialize agile, distributed manufacturing capacity for medical countermeasures. RPP 26-13-EDM focuses on end-to-end production of small-molecule drug substances and finished drug products, from key starting materials through regulatory filings and commercial-scale manufacturing. Full technical and cost proposals are now due November 9, 2026, at 5:00 p.m. ET.

This opportunity calls for more than a manufacturing concept. ASPR’s Industrial Base Management and Supply Chain program is seeking capacity that can adapt to changing demand, operate under current good manufacturing practices (cGMP), support multiple finished dosage forms, and remain commercially viable after the funded project ends.

What Is BioMaP Seeking for Proposals?

The RPP calls for advanced research and development of manufacturing systems that can produce both drug substances and finished drug products for medical countermeasures. BioMaP defines agile manufacturing as the ability to move quickly and adapt to change, and distributed manufacturing as production spread across multiple locations rather than concentrated in one facility. Multiple qualified U.S. sites operated by the same company can meet this requirement if they function as one agile, integrated system; independently operated regional sites are not required.

The focus is on CDER-regulated drug products for which generic versions are approved through ANDAs, regardless of molecular weight. Biologically derived production routes are eligible, but BLA-licensed biologics, including monoclonal antibodies, are out of scope. A specific medical countermeasure indication is not required for a government-approved product. Proposed capabilities should cover end-to-end production under cGMP, with a plan for the regulatory work needed to bring products to market. Depending on the product, that may include Drug Master Files, New Drug Applications, or Abbreviated New Drug Applications. Qualified laboratories, product verification, environmental and shelf-life testing, and applicable industry standards are also part of the scope.

BioMaP identifies several potential approaches, including modular and continuous manufacturing lines, integrated active pharmaceutical ingredient and finished-dose production, rapid-changeover equipment, automated quality monitoring, and smaller manufacturing systems that could operate closer to the point of need. Proposers must show how their approach can scale, maintain quality, strengthen domestic supply, and support commercial demand. Traditional batch manufacturing and reliance on global just-in-time supply chains will not be considered. However, hybrid processes combining continuous operations with inherently batch steps may qualify; fully continuous processing is preferred but is not required at every stage.

How Is the Project Structured?

The anticipated period of performance is up to 24 months, with work expected to begin in the first quarter of calendar year 2027. The technical requirements divide that work into two objectives.

Objective A is the base period, while Objective B is an option exercised based on Objective A results and funding availability. Objective B is not expected to be funded at award.

Objective	Duration	Expected work
A: Design and study	6 months	Select proposed small-molecule products, assess supply-chain dependencies, refine the manufacturing design, establish milestones, and develop regulatory, commercialization, and scale-up plans.
B: Manufacturing and validation	18 months	Establish end-to-end cGMP capacity, conduct production and validation runs, prepare for FDA inspection, engage FDA on the relevant regulatory route, and advance the filings needed for commercial sale.

Performers must be able to complete both objectives. Proposed drug products must be drawn from the ASPR or FDA essential medicines lists and receive government approval. The proposed manufacturing process for each product must start at Manufacturing Readiness Level 3 or higher; already-commercialized products are eligible when the project establishes new agile or distributed domestic capacity. At least one product must cover the full pathway from key starting material through API and finished dosage form, with multiple dosage forms required across the portfolio rather than for each product.

Foreign-sourced key starting materials or APIs may be used for development activities with a plan to transition to domestic production. Batches supporting regulatory filings and commercial production must use domestic key starting materials and APIs. Schedule II controlled substances must be sourced domestically at every stage.

Who Is a Good Fit?

This RPP is best suited to teams that can assemble an integrated manufacturing operation, not a company offering a single isolated technology. The statement of objectives anticipates multidisciplinary teams with expertise in pharmaceutical manufacturing, cGMP operations, chemistry and chemical engineering, automation, regulatory affairs, supply chain, industrial process development, and drug substance and drug product production. Teams may be led by industrial, academic, or nonprofit entities, with evidence of teaming arrangements included in the proposal.

The eligibility and long-term operating requirements warrant an early review. Offerors must join the BioMaP Consortium before award. The RPP also requires attestations concerning U.S. ownership, operation, headquarters, and where project work will occur, along with commitments that extend for years after performance ends. Proposed arrangements involving a sub-performer that does not meet the U.S.-owned and operated requirements require Agreement Officer authorization.

Cost sharing is preferred but not required. Proposers must still provide a capitalization plan and show how they will maintain the facilities and infrastructure needed for the manufacturing effort for at least 10 years after the project ends. They should also examine the RPP’s intellectual property, government-use, priority-access, and property provisions before deciding whether to bid. These requirements can affect the long-term business model as much as the initial award.

Key Dates and Submission Details

Milestone	Date
RPP released	September 21, 2026
Virtual teaming speed-networking event	September 25, 2026
Questions due	October 1, 2026, at 1:00 p.m. ET
Updated: Full technical and cost proposals due	November 9, 2026, at 5:00 p.m. ET

There is no white paper stage for this RPP. Offerors must submit a full Technical Proposal, a full Cost Proposal, and the additional eligibility and planning documents specified in the solicitation. The updated templates in Amendment 2’s Attachment C are mandatory. Proposals must be submitted through ATI’s Acquisition Management Platform; submissions by other means will not be accepted.

Prospective teams should also confirm platform access well before the proposal deadline, since an incomplete upload will not be accepted after the submission window closes.

How Will Proposals Be Evaluated?

BioMaP will first screen submissions for compliance. Qualified proposals will then be evaluated on technical approach, relevant experience, and cost or price, in that order of importance. The technical approach carries significantly more weight than relevant experience, which carries more weight than cost or price.

The evaluation asks whether teams can produce active pharmaceutical ingredients and finished dosage forms in an agile, distributed, cGMP-compliant manner, scale and commercialize their manufacturing capability, and demonstrate a sound understanding of FDA, DEA, and USP requirements. Relevant experience must be supported by one to five examples from the past five years.

ASPR anticipates multiple awards, though it may make one award, several awards covering different parts of the work, or no award. Proposals rated Acceptable through Outstanding that are not selected immediately may remain in BioMaP’s Basket for up to two years, where they could be considered if a later need and funding align. No total funding amount is specified in the RPP, and awards remain contingent on federal funding availability.

What Should Prospective Teams Do Now?

Start with a candid fit assessment. Can the proposed team carry a selected medicine from starting materials through cGMP drug substance and finished-product manufacturing, validation, regulatory submission, and commercial sustainment? A strong proposal will need to make those connections explicit, with credible partners, costs, milestones, and evidence of manufacturing experience.

The fastest useful next steps are to confirm consortium membership plans, identify the target product and its current manufacturing readiness, secure missing manufacturing or regulatory partners, review the 10-year commitments and IP terms, and begin the full technical and cost proposal using BioMaP’s required templates. For this RPP, commercial durability and domestic supply resilience are central to the technical case, not sections to fill in at the end.

EverGlade is a national advisory firm helping innovators navigate the federal funding ecosystem. We support companies across the funding lifecycle, from early-stage strategy through proposal development, negotiations, and post-award execution, ensuring you win the award and deliver the program.

For additional information on where your capabilities could plug into this solicitation, schedule a conversation with our team.

Collaborate with EverGlade

We partner with life sciences and technology innovators to secure and execute funding for high-risk, high-impact programs across the federal and commercial sectors.