ARPA-H Awards Up to $125 Million to Produce Personalized RNA Medicines
ARPA-H Awards Up to $125 Million to Produce Personalized RNA Medicines
On September 1, the US Advanced Research Projects Agency for Health, ARPA-H, awarded up to $125 million to five teams. The GIVE program is funding four automated manufacturing systems and a separate quality control system at the University of Utah. The aim is to produce small, personalized batches more quickly.
Personalized RNA therapy starts with a sequence designed for a specific patient. The RNA must then be synthesized, purified, packaged in lipid nanoparticles, which are lipid shells that deliver the molecule into cells, filled into vials, tested, and released as a batch. According to an ARPA-H estimate reported by Pharmaphorum, manufacturing some individualized genetic therapies takes months and costs hundreds of thousands of dollars. Every step in this process contributes to the total production time.
The five awards support different technical approaches. In the FUSE project, the liquid remains inside a disposable chip. The system is intended to combine manufacturing and quality control in less than three days. The closed chip allows part of the manufacturing process to move from a cleanroom into a compact device. A separate University of Utah system is intended to test a medicine against several parameters and release the batch within one day. It uses precise control of tiny liquid droplets, optical measurements, and AI.
The ESCALATOR project from Waterfall Scientific integrates the entire process into a single system. Enzymes create a DNA template, the molecule used to copy the RNA. The system then continuously synthesizes the RNA, forms lipid nanoparticles, and fills the vials. Automated quality control covers both the drug substance and the finished medicine.
In July, ARPA-H launched THRIVE, a program designed to reuse parts of the development process for personalized gene editors across different mutations. GIVE continues this work after the RNA sequence has been selected. It carries the sequence through manufacturing to a dose that has passed the required quality checks.