The Advanced Research Projects Agency for Health (ARPA-H) has announced a landmark Innovative Solutions Opening (ISO) for the BioStabilization Systems (BoSS) program, an ambitious effort to revolutionize how live cell-based therapies are stabilized, manufactured, and distributed. As outlined in the solicitation, BoSS aims to eliminate the field’s dependence on ultra-cold storage and transport, which currently constrains the accessibility, affordability, and scalability of advanced biologics such as cell and gene therapies (CGTs) . By pursuing breakthrough biostabilization technologies that allow cells to remain stable at ambient temperatures, BoSS seeks to fundamentally reshape the biotechnology infrastructure that underpins modern healthcare.
ARPA-H’s Scalable Solutions Office (SSO) designed this solicitation to catalyze next-generation approaches that mimic nature’s extremophile biology, adapt advanced biomaterials, and deploy innovative bioprocessing systems capable of gently stabilizing cells without cold chain requirements. The overarching goal is clear: enable a commercial-ready bioprocessing platform that can store, transport, and deliver high-quality cell-based products at room temperature, expanding access to advanced therapies for patients in every geography, including remote and resource-limited settings.
Inside the BoSS Solicitation: Scope and Research Objectives
BoSS seeks multi-party technical teams that develop coordinated solutions across two Technical Areas (TAs):
TA1 (BioPrep) focuses on cellular interventions that preserve structural integrity prior to biostabilization and enable rapid, high-quality re-animation following storage. These approaches must be reversible, safe, and capable of maintaining cell identity and potency after stabilization.
TA2 (Bioprocessing) centers on creating, adapting, or scaling instrumentation that can implement biostabilization in an aseptic, cell-friendly, commercially viable format. Systems must address parameters such as processing speed, scalability, reproducibility, and seamless integration with biomanufacturing pipelines.
Beyond technical R&D, BoSS includes an Independent Verification and Validation (IV&V) partner, which will supply authenticated clinical and research cell types, perform standardized cell characterization, and validate each performer’s stabilized cell outputs. This ensures that progress is measured consistently at key down-select points across the four-year program.
The solicitation defines a three-phase program structure, spanning 48 months:
- Phase 1 (15 months): Demonstrate feasibility of TA1 and TA2 approaches and meet minimum metrics such as achieving more than 14-day shelf life at ambient temperatures.
- Phase 2a and 2b (24 months): Integrate technologies into a unified bioprocessing system, demonstrate scalability, and align with FDA regulatory pathways and commercialization partners.
- Phase 3 (9 months): Prepare for market transition, refine system usability, and demonstrate comparability to cryopreserved controls.
Throughout all phases, awardees must meet increasingly stringent performance metrics covering cellular viability, apoptosis, metabolic activity, production speed, and shelf-life stability.
Key Dates for Proposers
ARPA-H outlines several critical deadlines in the ISO’s summary section:
Proposers’ Day: January 29, 2026 (8:00 AM to 5:00 PM ET)
Opportunity to engage directly with ARPA-H, ask clarifying questions, and support teaming.
Questions Deadline: January 22, 2026 at 5:00 PM ET
Last day to submit written questions to the agency.
For Technical Performers (TA1/TA2):
- Solution Summary due: February 19, 2026 at 5:00 PM ET
- Solution Pitch due: March 26, 2026 at 5:00 PM ET
For IV&V Partner Applicants:
- Solution Summary due: April 17, 2026 at 5:00 PM ET
- Solution Pitch due: May 15, 2026 at 5:00 PM ET
All materials are submitted through the ARPA-H Solutions Submission Portal.
Funding Expectations and Award Structure
ARPA-H anticipates issuing multiple awards under Other Transaction (OT) agreements, enabling flexible, milestone-driven execution. While total funding levels are not specified, the program is designed as a four-year effort, with down-selects after Phase 1, Phase 2a, and Phase 2b to ensure only the most promising, integratable, and commercially viable systems advance. Performer teams must operate within a multi-party teaming model, where all technical contributors are signatories to the OT and capable of leading at different stages of development.
Why BoSS Matters: Transforming Access to Cell-Based Medicines
The BoSS program represents a bold leap forward for biomanufacturing and global health. By enabling room-temperature stabilization of live cells, ARPA-H seeks to unlock safer, more affordable, and widely deployable biologic products. Success would ease supply chain burdens, reduce cost barriers for advanced cell therapies, improve emergency response capabilities, and extend high-value biologics to underserved populations.
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