Oral Presentation Australasian RNA Biology and Biotechnology Association 2026 Conference

Genetic Medicines and Individualized Manufacturing for Everyone (148293)

John Schiel 1
  1. Advance Research Project Agency for Health (ARPA-H, Washington, DISTRICT OF COLUMBIA, United States

Manufacturing genetic medicines for personalized and individualized (P/I) care remains constrained by centralized, complex, and costly production models. Current approaches rely on specialized facilities, optimization-intensive processes, and resource-heavy quality control (QC) systems, compounded by requirements for ultracold distribution. These barriers limit scalability and timely access, particularly for P/I therapies such as cancer neoantigen therapies, cell therapies, and gene-editing treatments. The ARPA-H Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program seeks to address these challenges by enabling a distributed, multi-site, multi-product biomanufacturing network for RNA-based genetic medicines. GIVE focuses on two technical areas: (1) advanced, automated RNA manufacturing technologies that simplify process development and production workflows, and (2) integrated QC platforms that can provide rapid and reliable release testing at or near the point of manufacture. GIVE aims to push the technological limits of throughput, footprint, and digital control to usher in a new era of individualized manufacturing and expand patient access to next-generation therapies.