ARPA-H BioStabilization Systems (BoSS)

Executive Summary:

The ARPA-H BioStabilization Systems (BoSS) program provides multi-year support for teams developing ambient-temperature cell stabilization and scalable bioprocessing systems. Performer Solution Summaries are due February 19, 2026.

How much funding would I receive?

ARPA-H anticipates multiple OT awards, with the expectation that Performer teams will be funded through multi-phase development (up to 48 months). While specific award ceilings aren't stated, ARPA-H OT programs typically support multi-million-dollar development efforts and note that several teams may be funded initially with down-selects in later phases.

What could I use the funding for?

The BioStabilization Systems (BoSS) program aims to transform how live cell-based therapies are stabilized, manufactured, and distributed. At its core, BoSS addresses a foundational bottleneck in the delivery of advanced cell and gene therapies (CGTs): the critical dependence on ultra-cold conditions (-80 to -196˚C) for storage and transport. BoSS will yield a bioprocessing system that enables scalable production of thermally stable cells, paving the way for a new era of efficient and resilient manufacturing and distribution of biologics without any need for cold storage. BoSS-developed technologies will also accelerate many other avenues in biotechnology that directly impact healthcare, including bio-surveillance, regenerative medicine, large-scale genetic testing, blood product supply, and wound repair, in addition to improving access to a wide range of existing biotherapeutics.

This ISO is intended to solicit:

1) Performer teams that can pioneer breakthrough cell stabilization technologies and integrate these technologies into a commercially viable system for producing cell therapy products at scale. Strategic partnerships are encouraged to best position technologies for commercialization success, such as assembling multidisciplinary teams that may include experts from academic, industry, regulatory, commercialization, and non-traditional backgrounds.

2) An Independent Verification and Validation (IV&V) partner to reliably provide well-characterized, clinically relevant, government-selected cells to Technical Area Performers. This partner will also assess cell viability and system performance at critical junctures throughout the program.

• Background

  This year approximately 150 million Americans will use at least one thermally unstable biologic, such as a monoclonal antibody, vaccine, or cell therapy. The instability of these medicines necessitates a reliance on cold chain, which jeopardizes product effectiveness, escalates costs, and limits access due to complex, temperature-dependent manufacturing and distribution schemes. Furthermore, costly ultra-cold cryopreservation is the standard approach to extending shelf-life stability for life saving biologics such as CGTs. However, demand for CGTs continues to surge, powered by their transformative impact on healthcare and reflected in rapid market expansion. Globally, there are now >3000 CGTs in the development pipeline, ranging from pre-clinical through pre-registration phases. Innovative solutions that relieve cold chain requirements while preserving shelf-life stability are crucial to meeting this rising demand, as FDA approval and widespread patient access to CGTs rely on maintaining product quality throughout storage and distribution.

  BoSS aims to develop innovative technologies that preserve cells at ambient temperatures, a breakthrough approach we will subsequently refer to as biostabilization. Achieving biostabilization remains a two-fold challenge that has yet to be overcome. The first challenge requires cellular interventions to preserve the integrity and function of vital elements prior to undergoing stabilization, enabling cells to withstand physical changes that would otherwise cause irreversible damage. This could include delivering protectants into cells and/or altering cells in other ways to improve processing and storage resilience. To maintain the clinical utility of cell products, cellular interventions to prepare and deploy biostabilization must be both biocompatible and reversible. The second challenge involves implementing aseptic, cell-friendly handling instrumentation to deploy stabilization techniques across various production scales.
  
  One approach to address the first challenge is to adopt nature’s strategies to accomplish biostabilization. For example, ‘anhydrobiotes’ can tolerate extreme loss of water and persist in a dehydrated state for years (e.g., tardigrades, rotifers, brine shrimp), quickly regaining full function after rehydration. Molecular contributors to this resilience have been elucidated such as amorphous trehalose glass and special classes of intrinsically disordered proteins (IDPs). Recent studies have revealed cell structure re-arrangements and stress-induced formation of molecular condensates that may be essential for surviving the stresses of dry processing. Other discoveries from the genomic to the organismal scale form the natural basis of desiccation tolerance and may be adapted or improved upon for biostabilization. Solutions inspired by chemistry and materials science advances are also encouraged along with approaches that employ biocompatible polymers, scaffolds, multi-organic frameworks, or cell encapsulation to protect and stabilize cells.

  Addressing the second challenge requires development of new processing approaches and potentially new instrumentation that can yield products suitable for ambient storage. Current gold standard methods for batch processing like lyophilization (freeze-drying) are energy-intensive, slow, and challenging to apply to complex biologics. While appropriate for proteins, antibodies, and even some vaccines, lyophilization is a risky and unproven approach for high-value cell products that are widely used in the biopharma industry as starting materials, manufacturing intermediates, host cells, and cell-based therapies. Nascent technologies like microwave-assisted vacuum foam-drying, thin film freeze-drying, and polymerization gelation exhibit potential for processing complex biologics but remain at a low manufacturing readiness level (MRL), i.e., early-stage development and requires significant development to establish full-scale production. Established technologies with high MRL, such as spray-drying, commonly used for food production, offer the advantage of continuous processing and may have potential for adaptation to biologics.
  

  Successful completion of BoSS will yield a bioprocessing system designed as a platform technology for stabilizing cell biologics capable of easy integration into biomanufacturing pipelines. The bioprocessing system will enable scalable production and distribution of thermally stable cells benefiting the biopharmaceutical ecosystem that uses cells as starting materials, manufacturing intermediates, and CGTs. Breakthroughs from BoSS are expected to yield biostabilization innovations including intracellular and extracellular protectants and stabilizers, enabling bioprocessing technologies, and re-animation products. Together, BoSS bioprocessing system and biostabilization technologies will be commercially viable solutions that will establish a new paradigm for biomanufacturing designed to reduce costs and ensure that biological medicines are accessible to patients, including those living in the most remote and resource-limited communities.

• Technical Areas

  BoSS envisions that successful solutions will converge from extremophile biology, biomaterials science, biomanufacturing, pharmaceutical formulation, process engineering, and device development to unlock new bioprocessing and biostabilization solutions, bridging historical silos in biostasis science and advancing biological medicines. Proposals are required to address solutions to both technical areas:
  
  Technical Area 1 (TA1): BioPrep

  Approaches to BioPrep include preparing, protecting, and other methods of intervention to allow cells to endure and recover from biostabilization at room temperature. BioPrep solutions should be reversible interventions that support the suspension of biological activity while ensuring cellular health and integrity upon reanimation. BioPrep solutions may also include the development of re-animation techniques and solutions that rapidly restore biological activities after biostabilization.
  
  Technical Area 2 (TA2): Bioprocessing

  Bioprocessing technologies (e.g., instruments, devices) should enable the deployment of biostabilization concepts at scale. Activities may include the scale-up of an early MRL, cell-friendly processing technology, or the adaptation of scaled systems that can be re-designed to safely and gently handle cells. The proposed solution should mitigate stress on cells while achieving biostabilization with preserved quality and function for extended durations at ambient temperatures.
  
  Proposers must submit proposals to both TAs. A conforming proposal will account for all program requirements outlined in this ISO, both TA-specific and overall program milestones and metrics.

• Program Overview

  Technology commercialization is a critical part of achieving the ARPA-H mission to improve health outcomes for all Americans. To support this goal, progress will be measured by strategic metrics and milestones that must be met to advance through subsequent phases. Technologies will advance across three integrated phases designed to drive both technical advancement and commercial translation:

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  Phase 1 focuses on establishing the scientific feasibility of ambient biostabilization. This proof-of-concept stage includes developing innovative cell preparation approaches with enabling instrumentation that, together, are capable of inducing biostabilization as well as re-animation methods to restore function after biostabilization.

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  Phase 2 emphasizes integrated capability demonstrations, converging biological and manufacturing innovations into a cohesive bioprocessing system that can produce stabilized cells under simulated commercial conditions.

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  Phase 3 advances to scaled solution development and industry transition, preparing the bioprocessing system for market entry through GMP-compliant production, strategic industry partnerships, and validation in real-world use cases.

  Performer teams must meet increasingly stringent technological capability requirements and stabilized cell quality metrics during each phase to demonstrate progress on biostabilization technology development. Performers will choose cells used for end of phase demonstrations from a list of government-selected cell types, which will be identified at the start of the performance period. Sub-phase milestones may be demonstrated on cell types chosen by the Performer, with consideration to the restrictions identified in Table 1. In later stages, end of phase demonstrations will be permitted on cells that are aligned with Phase 3 transition partners. Ideal transitional partners for Performers are organizations equipped with established distribution networks to seamlessly integrate the developed bioprocessing system into their existing biomanufacturing pipelines for cell biologics, accelerating the path from innovation to implementation.

  At the end of the program, biostabilization technologies will demonstrate capability, scalability, and applicability of commercially viable platform technologies that enable room temperature storage and distribution of stabilized cells agnostic of cell type, supporting widespread access to biologic medicines. The ideal bioprocessing system will integrate seamlessly with biomanufacturing and fill-finish systems. Ultimately, partnerships will culminate into early adoption of a new commercially viable bioprocessing system capable of scalable production of stabilized cell products that meet Good Laboratory Practice (GLP) and GMP standards with a path paved for commercialization to support broad industry adoption.

Are there any additional benefits I would receive?

Beyond the primary funding, BoSS awardees gain several indirect strategic advantages:

Government Validation & Credibility
Selection by ARPA-H establishes strong scientific legitimacy and positions your technology as a potential national-level biomanufacturing platform.

Enhanced Visibility & Notoriety
Awardees are featured through ARPA-H communications, Proposers’ Day events, and industry engagement, increasing recognition among biotech investors, health systems, and biopharma manufacturers.

Access to a National Innovation Network
BoSS includes structured engagement with an Independent Verification & Validation (IV&V) partner, FDA interactions, and optional commercialization support—creating opportunities for partnerships, pilot studies, and eventual technology adoption.

Stronger Exit, Growth, and Acquisition Potential
Nondilutive development of platform technologies can significantly improve valuation, especially for companies working in CGT manufacturing, biosurveillance platforms, or enabling bioprocessing technologies. Government validation reduces perceived technical risk for acquirers and later-stage investors.

What is the timeline to apply and when would I receive funding?

Key dates:

• Proposers’ Day: January 29, 2026

• Performer Solution Summary: February 19, 2026

• Performer Pitch: March 26, 2026

• IV&V Solution Summary: April 17, 2026

• IV&V Pitch: May 15, 2026

Where does this funding come from?

Funding is issued through the Advanced Research Projects Agency for Health (ARPA-H), under the Scalable Solutions Office, using Other Transaction (OT) authority for high-risk, high-impact biomedical innovation.

Who is eligible to apply?

Universities, Nonprofits, Small and large commercial businesses, Non-U.S. entities (with restrictions; must not be from foreign entities of concern), Must conduct work in the U.S., FFRDCs and U.S. Government entities cannot participate as Performers.

What companies and projects are likely to win?

See full solicitation for details. Strong candidates include companies with capabilities in:

• Cell & gene therapy engineering

• Bioprocessing & biomanufacturing instrumentation

• Biomaterials, polymers, encapsulation, or intracellular protectants

• Cell preservation technologies (cryopreservation alternatives, desiccation biology)

• Microfluidics, closed-system processing, or continuous manufacturing

• Regulatory-ready biologics or device development expertise

• Advanced analytical platforms (cell viability, potency, functional assays)

Winning projects will propose integrated TA1 + TA2 solutions capable of achieving:

• Room-temperature stability (14 days → 3 months)

• Reanimation <1 hour by Phase 3

• High viability, function, and potency metrics across multiple cell types

Are there any restrictions I should know about?

Key restrictions include:

• No genetic manipulation of cells

• No dangerous gain-of-function research (per EO 14292)

• No demonstrations on RBCs or microbial species

• No slow (>4 hr prep or >1 day processing) methods

• No methods that cannot scale or meet GMP requirements

• No traditional lyophilization

• Teams must maintain SAM.gov registration for Step 2

How long will it take me to prepare an application?

For a first-time applicant, preparing a solution summary under this opportunity will likely take 50-70 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth under Federal & State R&D Initiatives.

How much would BW&CO Charge?

Our full service support is available for a flat fee of $4,000 to submit a solution summary.

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Resources

See the full solicitation here.