Waterfall Scientific has been awarded up to $54.5 million from the Advanced Research Projects Agency for Health, or ARPA-H, to lead a six-company consortium developing a continuous-flow platform for manufacturing and characterizing mRNA medicines.
The project, called ESCALATOR, is being conducted under ARPA-H’s Genetic Medicines and Individualized Manufacturing for Everyone, or GIVE, program.
Waterfall Scientific will serve as prime contractor alongside consortium partners Ansa Biotechnologies, Volta Labs, Polymorphic Biosciences, Tensentric and Ginkgo Bioworks.
The consortium plans to develop an end-to-end continuous-flow manufacturing platform capable of rapidly producing and characterizing high-purity mRNA therapeutics and vaccines on demand.
The platform will combine microfluidic DNA synthesis, RNA transcription, purification, formulation, fill and finish capabilities with automated drug substance and product characterization.
The effort is designed to address limitations of traditional batch-based mRNA manufacturing, including production bottlenecks, high costs and scalability challenges.
Ansa Biotechnologies will provide enzymatic DNA synthesis technology, while Volta Labs will contribute automated fluid handling and sample preparation capabilities.
Polymorphic Biosciences will provide lipid nanoparticle formulation technology. Tensentric will lead custom hardware design and support system integration and commercial prototyping, while Ginkgo Bioworks will contribute system integration and computational optimization capabilities.
Waterfall said the resulting architecture is intended to reduce manufacturing footprints and unit costs while cutting production lead times for mRNA therapeutics from weeks to days.
Potential applications include pandemic response, personalized oncology, rare disease therapeutics and global health programs.
Waterfall Scientific is a Massachusetts-based biotechnology company spun out of the University of Massachusetts Amherst using technology developed in the laboratory of co-founder and Chief Scientific Officer Craig T. Martin, Ph.D. Its DuoTether continuous-flow system is designed to improve the purity and efficiency of mRNA synthesis.
KEY QUOTES:
“Leading this landmark ARPA-H initiative alongside such exceptional consortium partners marks a pivotal milestone for Waterfall Scientific as we advance our innovative technology. This award strongly endorses our continuous-flow paradigm. By uniting best-in-class capabilities across enzymatic DNA synthesis, formulation, microfluidics, automated hardware, and high-throughput analytics, we are establishing a scalable platform that will redefine how nucleic acid therapies are manufactured globally.”
Inna Shcherbakova, Ph.D., Co-Founder and Chief Executive Officer of Waterfall Scientific
“This investment provides a truly exciting opportunity to move our promising technologies from concept to meaningful impact. We look forward to working with ARPA-H and our collaborators to deliver results for patients, providers, and communities.”
Melissa J. Moore, Ph.D., Co-Founder of Waterfall Scientific
