ARPA-H launches program to ignite innovative biomanufacturing for cell and gene therapies

Scalable manufacturing technology could make genetic medicines widely available 

The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced a new funding opportunity through its Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program. With cutting-edge production technologies, the program seeks to establish the U.S. as a frontrunner in advanced manufacturing methods for high-quality genetic medicines. 

Genetic medicines have an unrivaled potential to treat the root causes of rare genetic conditions, cancer, chronic diseases like cystic fibrosis and liver or cardiovascular disorders, autoimmune diseases, and infectious diseases. The promise of genetic medicines lies in the ability to make treatments in different formats. Their development is often hindered by the high cost and complexity of manufacturing and quality testing, centralized facilities with specialized equipment needs, and ultracold shipping requirements.  

“The manufacturing hurdles facing genetic medicine slows innovative research and prevents potentially lifesaving, affordable treatments and preventions from getting to the American people,” said ARPA-H Acting Director Jason Roos, Ph.D. “By using advanced innovative technologies for personalized manufacturing, GIVE has the potential to transform the market for genetic medicines with America at the forefront.” 

The GIVE program aims to unleash U.S. biomanufacturing technology for genetic medicines by bringing state-of-the-art production closer to the point of care. The program envisions a distributed manufacturing process combined with automated quality assurance. Locally manufactured medicines can be delivered faster and cost less without compromising quality. Alternative approaches that align with the program’s vision, timeline, and ambitious expectations are also welcome. GIVE’s results may streamline research and development efforts for new products, unlocking a new treatment paradigm and business model. 

“Our vision is to rapidly produce multiple kinds of genetic medicines so that breakthrough treatments are accessible, affordable, and ready to dose within a week of diagnosis,” said GIVE Program Manager John Schiel, Ph.D. “Individualized domestic biomanufacturing will give the U.S. an advantage and ensure that researchers and patients alike have access to the latest therapeutic capabilities.” 

ARPA-H seeks to engage bold thinkers with revolutionary ideas and anticipates that teaming will be necessary to achieve the goals of GIVE. Prospective proposers are encouraged to form teams with varied technical and operational expertise to submit a research proposal. Other Transactions Agreements (OTAs) (not procurement contracts, grants, or cooperative agreements) under this ISO are anticipated. Investments will depend on the quality of the proposals received.   

Learn more about GIVE on its program page, including information about the ISO solicitation and Proposers’ Day registration.