BioStabilization Systems (BoSS)

Quick Summary

The Advanced Research Projects Agency for Health (ARPA-H), under the National Institutes of Health, has issued a Solicitation for the BioStabilization Systems (BoSS) program. This initiative seeks innovative solutions to develop a bioprocessing system for stabilizing live cell-based therapies at ambient temperatures, eliminating the need for ultra-cold storage. This will transform the manufacturing and distribution of advanced cell and gene therapies (CGTs) and accelerate biotechnology advancements. Solution Summaries for Performers are due February 19, 2026, and for IV&V partners, April 17, 2026.

Program Overview

The BoSS program aims to overcome the critical dependence on ultra-cold conditions (-80 to -196°C) for storing and transporting live cell-based therapies. The goal is to develop a bioprocessing system that enables scalable production of thermally stable cells, facilitating efficient and resilient manufacturing and distribution of biologics without cold storage. This technology will also benefit bio-surveillance, regenerative medicine, genetic testing, blood product supply, and wound repair.

Scope of Work

Proposals are sought for two primary technical areas and an Independent Verification and Validation (IV&V) partner:

• Technical Area 1 (TA1) - BioPrep: Focuses on developing methods to prepare, protect, and intervene in cells to enable them to endure and recover from room-temperature biostabilization, ensuring reversibility and cellular health upon reanimation.
• Technical Area 2 (TA2) - Bioprocessing: Focuses on developing instruments and devices for the scaled deployment of biostabilization concepts, including aseptic handling, streamlined operations, and achieving biostabilization at ambient temperatures.
• IV&V Partner: An IV&V partner is required to assess performer progress and data credibility.

Contract Details

• Type: Multiple Other Transaction (OT) Agreements.
• Duration: A 4-year (48-month) effort, structured 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. All responsible sources, including universities, non-profit organizations, and businesses of all sizes, are eligible. FFRDCs and other Government entities are generally not permitted as Performers.

Submission & Evaluation

• Submission Process: A two-step process involving a Solution Summary submission, followed by a Solution Pitch presentation and virtual oral presentation.
• Key Deadlines:
  • Performer Solution Summary Due: February 19, 2026, 5:00 PM ET
  • Performer Solution Pitch Due: March 26, 2026
  • IV&V Partner Solution Summary Due: April 17, 2026, 5:00 PM ET
• Submission Site: https://solutions.arpa-h.gov/Submit-Solution/
• Evaluation Criteria: Overall Scientific and Technical Merit, Proposer's Capabilities and/or Related Experience, Potential Contribution to Relevance to the ARPA-H Mission and User Experience, and Assessment of Proposed Cost/Price.
• Requirements: Proposers must have an active SAM.gov registration.

Amendments

This opportunity has been amended multiple times. Amendment 3 made minor text changes to the Cost Proposal Narrative and Spreadsheet. Amendment 2 clarified out-of-scope approaches, updated capability requirements, allowable IV&V partner entity types, and reporting requirements. Amendment 1 corrected a formatting error. Interested parties should review the amended ISO for all changes.