ATCC has been selected by the Advanced Research Projects Agency for Health (ARPA-H) as an affiliate to provide independent verification and validation (IV&V) for its BioStabilization Systems (BoSS) program. Through this program, BoSS is taking the "200-degree leap," from -196 °C toward room temperature, to make life-saving cell therapies as easy to store and ship as aspirin.
Cold-chain preservation and transportation remain significant challenges for cell-based technologies, requiring specialized infrastructure to maintain product viability and function. The cold chain adds tens of billions of dollars a year in cost and can destroy a single dose worth hundreds of thousands of dollars with a single adverse temperature excursion. Reducing reliance on cold-chain dependence could help close the affordability gap, simplify distribution, and expand patient access to cellular medicines, particularly in settings where refrigerated storage and transport are difficult to maintain. ATCC will provide an independent framework for evaluating these technologies and generate standardized, reproducible data to support program decision-making.
Under the award, ATCC will provide working cell banks of government-selected cell types and standardized benchmarks to BoSS performers, drawing on capabilities developed through our experience with advanced preservation and assay-ready cells. ATCC will independently evaluate how well emerging stabilization technologies preserve cell quality and performance.
ATCC brings together the authenticated biological materials, scientific expertise, quality infrastructure, and program execution capabilities needed to independently evaluate emerging technologies, We are pleased to bring those capabilities to ARPA-H in support of addressing an important challenge in expanding patient access to advanced medicine."
Becky Bradford, Senior Vice President, ATCC Federal Solutions
ATCC will assess each stabilization technology's reproducibility, scalability, ease of use, and overall suitability, maintaining quality-controlled traceability throughout the program. As technologies progress, these evaluations will provide objective data to inform ARPA-H's comparison of approaches.
"We are proud to receive our first award from ARPA-H and to support the mission of its Scalable Solutions Office," said Eldar Imanverdi, senior director of Business Development, ATCC Federal Solutions. "We look forward to contributing ATCC's capabilities to this high-risk, high-reward research, which could help bring transformative health solutions to more people."