The Big Question

What if we could manufacture any genetic medicine anywhere in the U.S.? 

The Problem

RNA-based genetic medicines hold tremendous promise as treatments or preventions for cancer, rare genetic disorders, infections, and other chronic illnesses like autoimmune or cardiovascular diseases. However, they are expensive to manufacture and require centralized equipment, specialized facilities, complex manufacturing optimization, and resource intensive quality control systems. Requirements for ultracold storage and shipping add to the cost and complexity of manufacturing these drug products, especially for personalized and individualized (P/I) genetic medicines. Without innovative manufacturing processes, many products may never advance out of early-stage research and development.  

The Solution

The Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program aims to enable a multi-site, multi-product, and multi-scale biomanufacturing network. The goal of the program is to develop reliable, simple to use, distributed manufacturing and quality control platforms for RNA-based genetic medicines. GIVE’s two focus areas include advanced technologies for automated RNA manufacturing and integrated quality control platforms. By bolstering U.S. biomanufacturing technology, GIVE seeks to first-shore P/I genetic medicine manufacturing and improve patient access to cancer therapies, cell therapies, and gene editing technologies.  

Why ARPA-H

Through its health innovation network, ARPA-H can bring together biomanufacturing experts, equipment vendors, researchers, and small and large businesses in the industry to achieve the vision of the GIVE program.