Production of Drug Substances and Drug Products at Commercial Scale: Anti-Microbials and Large Volume Parenterals
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Executive Summary:
BARDA (through the BioMaP-Consortium) is looking to fund commercial-scale (“population scale”) domestic production of at least one (1) key starting material (KSM), drug substance, and/or drug product—with a stated preference for Anti-Microbials and Large Volume Parenterals (LVPs). This is an Enhanced White Paper solicitation, and the deadline is March 9, 2026, 1:00 PM ET (late submissions may not be evaluated).
How much funding would I receive?
Total estimated funding (all projects): approximately $200 million (subject to availability and adjustment).
Award size per project is not specified in the RPP.
The Government anticipates making multiple awards and also reserves the right to make one, multiple, or no awards.
What could I use the funding for?
Below are the uses that map directly to the RPP’s objectives and deliverables.
1) Objective A: Engineering design + study phase (design/refine the approach)
You can propose work to design and refine an end-to-end, scalable manufacturing concept that supports population-scale production, including:
Select at least 1 target drug substance jointly with the Government (minimum entry: MRL 6), including selection rationale.
Build a detailed list of molecules/molecule classes, required materials, systems, and equipment across manufacturing phases.
Develop and refine an analytical/characterization and manufacturing plan for population-scale production with automated and integrated processes across design, manufacturing, testing, and analysis—intended to increase MRL to 10 and meet U.S. Pharmacopeia standards and ICH guidelines for purity, potency, safety, validation, quality, etc.
Include an infrastructure governance framework (management structure, partnerships, scheduling considerations).
Assess domestic market maturity and conduct a risk assessment of domestic capabilities.
Present Objective A results and a plan for Objective B for Government approval to proceed.
2) Objective B: Demonstrate the model + population-scale manufacturing
If approved to proceed after Objective A, you can propose to:
Develop and execute an analytical model and demonstrate manufacturing of a KSM/API progressing from MRL 6/7 to MRL 10, in compliance with USP and ICH expectations.
Run multiple scenarios/production runs to test assumptions and identify conditions that improve or worsen:
Shortest time to market
Lowest development/deployment costs
Optimal time-to-market with cost tradeoffs
Key drivers of time and cost
Recommendations for future investment to enable population-scale production in real markets
Produce required program outputs (e.g., technical batch reports, final technical report with variables/assumptions/model runs).
The RPP also lists deliverables tied to drug products, including registration batches, completion of environmental/engineering/registration batch runs, and ANDA filings for each drug product (as applicable to your scope).
3) Program management + risk + schedule deliverables
You can include work to:
Manage the full program (integration, coordination, milestone schedule, critical path, go/no-go criteria).
Maintain a risk register and report risk changes.
Deliver required monthly technical progress reports and other specified deliverables.
4) Domestic industrial base / capacity expansion (U.S. soil)
The RPP states proposals are expected to be focused on United States investments, and capacity expansion work must be executed within the continental U.S. and its Territories (even for overseas-based companies).
Are there any additional benefits I would receive?
This is under BARDA’s BioMaP-Consortium OTA vehicle (OTA Number 75A50123D00003) and executed via Project Agreements under the consortium framework.
Proposals rated Acceptable through Excellent but not immediately funded may be placed into an electronic “Basket” for up to 2 years, remaining eligible for award during that time (if funding becomes available and after review of a Full Cost Proposal and SOW).
What is the timeline to apply and when would I receive funding?
Key solicitation dates
RPP Issue Date: February 6, 2026
Virtual Teaming Speed Networking Event: February 12, 2026
Questions due: February 18, 2026 (by 1:00 PM ET) (submit via email to biomap-contracts@ati.org)
Enhanced White Papers due: March 9, 2026 (by 1:00 PM ET)
Award / performance timing
Anticipated Period of Performance: not to exceed 24 months.
Offerors should plan for PoP to begin in Quarter 3 of Government Fiscal Year 2026 (Government may change start date via negotiations).
Where does this funding come from?
Strategic oversight is provided by BARDA.
The RPP references program interests from:
ASPR IBMSC Office (Advanced Manufacturing Domain)
HHS Defense Production Act (DPA) Title III Program (with preference for projects strengthening security of supply for items on the FDA List of Essential Medicines).
Who is eligible to apply?
Minimum eligibility criteria (must meet):
You must be a BioMaP-Consortium member prior to award of a Project Agreement.
You must show demonstrated experience in scalable manufacturing of KSMs/APIs and finished product form drugs, specifically at or beyond MRL 6.
Cost share is required to be eligible (must describe amount, whether cash or in-kind, and valuation method).
What companies and projects are likely to win?
Based on the stated evaluation factors and technical objectives, the strongest submissions will typically be those that:
Propose a credible path to population-scale production (hundreds of millions of doses) with domestic production capacity.
Clearly align to the preference area: Anti-Microbials and Large Volume Parenterals.
Demonstrate capability to move from MRL 6/7 to MRL 10 with strong USP/ICH-aligned quality/compliance planning.
Present an integrated approach (automation, analytics, validation/QC, supply chain, and governance) with clear milestones and risk controls.
Show meaningful, well-supported cost share.
Bring a multidisciplinary team with relevant industrial execution experience, and (encouraged) small business utilization.
Are there any restrictions I should know about?
Yes—several are explicit:
Submission method: Enhanced White Papers must be submitted online via BIDS; no other submission methods accepted.
Deadline enforcement: Late Enhanced White Papers may not be evaluated.
Format limits: Enhanced White Paper maximum 15 pages (excluding cover page and specified appendices); mandatory template/headers required.
Domestic expansion requirement: Capacity expansion work must be executed within the continental U.S. and its Territories (per Base Agreement requirement referenced in the RPP).
DPA domestic source compliance: Offeror must be compliant with the DPA definition of a “domestic source” (50 U.S.C. 4552(7)).
Regulatory compliance: Expected compliance with relevant FDA, DEA, USP and cGMP practices.
Salary rate limitation: Direct salary above Federal Executive Schedule Level II is unallowable under the OTA.
SAM.gov / UEI: A UEI from SAM.gov is required prior to award.
Security requirements: Attachment B lists ASPR deliverables and security requirements that may be required for resulting projects.
How long will it take me to prepare an application?
What the RPP requires:
A compliant Enhanced White Paper using the mandatory template (plus required appendices).
Enough detail to be evaluated on Technical Approach/Solution, Relevant Experience, and a Cost/Price ROM estimate.
A clearly described cost share package (required for eligibility).
A credible timeline that addresses the stated Schedule Objectives (Objective A and Objective B planning within a total PoP ≤ 24 months).
Practically, teams that are already organized and have MRL 6+ manufacturing readiness typically need to pull: technical narrative, milestones, ROM build-up, teaming roles, and cost share substantiation—plus ensure consortium membership is in place prior to award.
How can BW&CO help?
BW&CO can support you by turning this RPP into a submission-ready package, including:
A compliance-driven Enhanced White Paper outline and draft aligned to Attachment A headers
A reviewer-style gap check against eligibility requirements (MRL, consortium membership timing, domestic source, cost share)
A strong Objective A/Objective B story with measurable milestones and deliverable mapping
ROM narrative support (assumptions, labor categories, subcontractor framing) and cost share packaging
Final “red team” editing for clarity and evaluator alignment.
How much would BW&CO Charge?
Fractional support is $300 per hour.
For startups, we offer a discounted rate of $250 per hour to make top-tier consulting more accessible while maintaining the same level of strategic guidance and proposal quality.
Additional Resources
Review the solicitation here.