ARPA-H Awards Up to $87M to Develop Room-Temperature Cell Therapy Storage and Transport

The U.S. Advanced Research Projects Agency for Health (ARPA-H) has awarded four contracts under its BioStabilization Systems (BoSS) program to develop technologies aimed at enabling cell-based biologic medicines to be produced, stored and transported at room temperature.

Image courtesy of ARPA-H

ARPA-H has committed up to $87 million across the four-year program, with three teams working on cell stabilization technologies and a fourth organization providing independent verification and validation. Funding varies by team and is contingent on meeting research milestones.

The program targets what ARPA-H describes as a "200-degree leap" from ultra-cold storage at around -196°C to temperatures close to 21°C.

Many cell-based therapies rely on uninterrupted ultra-cold storage between the manufacturing site and the point of care. ARPA-H said a shipping delay or cryogenic container failure can result in the loss of a single dose worth hundreds of thousands of dollars. It estimates that reliance on frozen storage adds tens of billions of dollars in costs annually, while creating a significant logistical barrier to wider patient access.

Three performer teams have been selected to pursue different approaches to cell stabilization.

DesiCorp will lead a consortium developing biocompatible formulations and a thin-film freeze-drying system designed to stabilize cells at room temperature. The team includes the University of Louisville, the University of Texas at Austin, Via Therapeutics, VeriSIM Life and Ossium Health.

Charles Stark Draper Laboratory will lead a second team using AI-assisted experimental design and freeze-assisted droplet drying to develop stable cell products. Partners include Likarda, CPSI Biotech, OFC Life Sciences, Case BioSciences, the University of Colorado Boulder, Fresenius Kabi and MiNK Therapeutics.

A third team led by the University of California, Davis will use light-responsive gels and microfluidic processing techniques to induce a low-metabolic state in cells, with the goal of maintaining stability at room temperature. Partners include Mayo Clinic, Case Western Reserve University, the University of Georgia and Sersense.

The American Type Culture Collection (ATCC) will serve as the program's independent verification and validation partner. It will provide working cell banks of government-selected cell types and assess the viability and function of preserved products, as well as the design features of the preservation systems.

All three performer teams are expected to work with transition partners and apply their technologies to a cell therapy toward the end of the program. Development will proceed through multiple phases, with progress assessed against increasingly stringent benchmarks for cell viability, production speed and shelf-life stability.

The technologies remain under development, and the program does not represent the launch of a commercial room-temperature cell therapy storage or transport solution. If the program meets its objectives, ARPA-H says it could lower the cost of cell-based medicines, reduce the risk of product losses and enable domestic reserves for public health preparedness.

To learn more about BoSS, visit the program page.

Source: ARPA-H