Biofab foundry: a scalable, closed, automated, medical product manufacturing system
Active Definitive Contract Awarded Last action
- Contract number
- 75F40124C00124
- Awardee
-
Advanced Regenerative Manufacturing Institute Inc. UEI LA8CKGSANQG7
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $2,236,097
Award facts
- Contract value 100% obligated
- $2,236,097.00 Current and potential, with all options
- Completion date 69% complete
- Current and potential, with all options
- Contracting staff
- NAICS code
- 541720 Research and Development in the Social Sciences and Humanities
- PSC
- AJ11 General Science And Technology R&D Services; General Science And Technology; Basic Research
- Set-aside
- No set-aside
- Competition
- Full and Open Competition · 1 offer Negotiated Proposal / Quote
- Pricing
- Cost No Fee
- Place of performance
- Manchester, NH 03101, USA
- Legislative mandates
-
- Employment Eligibility Verification (E-Verify) FAR subpart 22.18
Award details come from SAM.gov/FPDS.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Supplemental Agreement for work within scope | $669,200 | |
| Other Administrative Action | $0 | |
| Original award | $1,566,897 |
About this award
The Food and Drug Administration awarded Advanced Regenerative Manufacturing Institute Inc. (Armi), a non-profit organization based in Manchester, New Hampshire, a definitive contract valued at $2.24M for the Biofab Foundry initiative. This contract, awarded on September 19, 2024, represents an extension of the period of performance through September 29, 2027, with a modified technical approach and increased funding relative to the original award. The Biofab Foundry project focuses on developing a scalable, closed, and fully automated medical product manufacturing system designed to advance domestic biomanufacturing capabilities and support the production of tissue-engineered and regenerative medicine products. This effort aligns with FDA's broader objectives to strengthen U.S. biomanufacturing infrastructure and enable innovative medical device and therapeutic production. No set-aside designation was applied to this award.
The contract is structured as a cost-no-fee arrangement, indicating a non-profit cost reimbursement model appropriate for Armi's status as a research and development organization. Armi's selection reflects its established track record in advancing biomanufacturing technologies, standardization protocols for cell and tissue-based research, and collaborative partnerships with government agencies, academic institutions, and private sector entities. The organization's prior work, including NIST-funded standardization initiatives and Economic Development Administration grants totaling approximately $45M for establishing Southern New Hampshire as a hub for regenerative tissue and organ production, demonstrates substantial capability in this specialized domain. Performance of the contract will take place at Armi's Manchester, New Hampshire facility.
Quick answers
Who was awarded contract 75F40124C00124?
75F40124C00124 was awarded to Advanced Regenerative Manufacturing Institute Inc. by Food and Drug Administration (Department of Health and Human Services) on September 19, 2024.
How much is contract 75F40124C00124 worth?
The government has obligated $2,236,097 on 75F40124C00124.
Was contract 75F40124C00124 competed?
The extent of competition for 75F40124C00124 was full and open competition. The government received 1 offer.
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