The US health research agency ARPA-H has awarded up to $125 million across five teams to build automated systems capable of producing personalised RNA medicines in under a week.
The funding forms part of ARPA-H’s GIVE programme, which stands for Genetic Medicines and Individualized Manufacturing for Everyone, targeting the speed and accessibility of genetic medicine production.
RNA-based therapies hold significant promise as treatments for cancer, rare genetic disorders, infectious diseases, and chronic conditions including autoimmune and cardiovascular diseases.
Despite their potential, RNA medicines remain expensive and logistically complex to manufacture, requiring centralised facilities, specialised equipment, and resource-intensive quality control systems.
Ultracold storage and shipping requirements further add to costs and complexity, particularly for personalised treatments tailored to individual patients.
ARPA-H has warned that without innovative manufacturing processes, many promising RNA products may never advance beyond early-stage research and development.
Biotechnology firm Waterfall Scientific has been selected to lead a six-company consortium under the GIVE programme, securing an award of up to $54.5 million for a project titled ESCALATOR.
Consortium partners include Ansa Biotechnologies, Volta Labs, Polymorphic Biosciences, Tensentric, and Ginkgo Bioworks, all joining Waterfall Scientific on the ESCALATOR project.
The consortium will integrate advanced technologies to establish an end-to-end, continuous-flow platform for rapid, on-demand production and characterisation of high-purity messenger RNA therapeutics and vaccines.
Traditional mRNA manufacturing relies on batch-based processes that create production bottlenecks, high costs, and significant scalability challenges, problems that become especially acute during public health emergencies.
Other awardee teams under the GIVE programme are developing a range of complementary platforms, including cartridge-based DNA and RNA manufacturing systems and fully automated benchtop continuous-flow production units.
Further funded projects include a platform combining automated DNA synthesis with chip-based RNA production, as well as an all-in-one genetic medicine testing platform enabling full quality control and lot release within as little as one day.
ARPA-H’s broader ambition through the GIVE programme is to develop reliable, simple-to-use, distributed manufacturing and quality control platforms that can serve patients well beyond centralised research facilities.