BioStabilization Systems (BoSS)
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Advanced Research Projects Agency for Health (ARPA-H), under the Department of Health and Human Services, has issued an Innovative Solutions Opening (ISO) for the BioStabilization Systems (BoSS) program. This initiative aims to transform the stabilization, manufacturing, and distribution of live cell-based therapies by eliminating the need for ultra-cold storage. Solution Summaries for Performers are due February 19, 2026, and for IV&V partners by April 17, 2026.
Program Overview
The BoSS program addresses a critical bottleneck in advanced cell and gene therapies (CGTs) by seeking to develop a bioprocessing system for scalable production of thermally stable cells. This will enable efficient manufacturing and distribution of biologics without cold storage, benefiting healthcare areas like bio-surveillance, regenerative medicine, and large-scale genetic testing.
Scope of Work
Proposals must address two technical areas:
- Technical Area 1 (TA1): BioPrep: Focuses on developing methods to prepare, protect, and intervene in cells to allow them to endure and recover from biostabilization at room temperature, ensuring cellular health and integrity upon reanimation.
- Technical Area 2 (TA2): Bioprocessing: Focuses on developing instruments and devices for the scaled deployment of biostabilization concepts, including technologies for aseptic handling and streamlined operations at ambient temperatures.
Contract & Timeline
- Type: Multiple Other Transaction (OT) Agreements.
- Duration: A 4-year (48-month) effort, divided into three phases: Phase 1 (15 months - proof-of-concept), Phase 2 (24 months - integrated capability demonstration), and Phase 3 (9 months - scaled solution development and industry transition).
- Set-Aside: None specified. Open to all responsible sources, including universities, non-profit organizations, and businesses of all sizes.
- Key Deadlines:
- Performer Solution Summary Due: February 19, 2026, 5:00 PM ET
- IV&V Partner Solution Summary Due: April 17, 2026, 5:00 PM ET
- Performer Solution Pitch Due: March 26, 2026
- Published Date: May 14, 2026 (latest amendment).
Submission & Evaluation
The submission process involves a two-step approach: an initial Solution Summary submission, followed by a Solution Pitch presentation and virtual oral presentation for selected candidates. Evaluation criteria include:
- Overall Scientific and Technical Merit
- Proposer's Capabilities and/or Related Experience
- Potential Contribution to Relevance to the ARPA-H Mission and User Experience
- Assessment of Proposed Cost/Price Eligible proposers include all responsible sources; however, Federally Funded Research and Development Centers (FFRDCs) and other Government entities are generally not permitted to respond as part of a Performer team. Multi-party teaming arrangements are required.
Amendments
This opportunity has undergone several amendments. Amendment 3 updated Attachments 3 (Cost Proposal Narrative) and 4 (Cost Proposal Spreadsheet). Amendment 2 clarified out-of-scope approaches, updated capability requirements, allowable IV&V partner entity types, and reporting requirements within the ISO.
Additional Notes
An Independent Verification and Validation (IV&V) partner is also being sought. Proposers must have an active registration in SAM.gov. Submissions must be made via the ARPA-H Solution Summary Submission Site: https://solutions.arpa-h.gov/Submit-Solution/.