Massachusetts-based biotech Waterfall Scientific has announced it has been selected by the Advanced Research Projects Agency for Health (ARPA-H) to lead a six-company consortium under the Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) programme.
The project — called ESCALATOR (Engineering a Small-scale, Continuous-flow manufacturing Apparatus to Launch A Transformational Overhaul for RNA medicines) — will bring together industry leaders in cell-free nucleic acid synthesis, LNP formulation, microfluidics, advanced analytics and hardware and software engineering.
ARPA-H will support the project with an award of up to $54.5m, aiming to integrate advanced technologies to establish an end-to-end, continuous-flow platform capable of rapid, on-demand production and characterisation of high-purity mRNA therapeutics and vaccines.
Waterfall Scientific will be the prime contractor and lead the consortium.
Why this matters
Traditional mRNA manufacturing often relies on batch-based processes, leading to production bottlenecks, high costs and scalability challenges.
These issues become even more pronounced during public health emergencies or when deploying personalised medicines.
The ESCALATOR platform aims to address these challenges by creating a fully integrated system that includes microfluidic DNA synthesis, RNA transcription, purification, formulation and fill/finish operations, all combined with an automated system for characterising drug substances and products.
"Leading this landmark ARPA-H initiative alongside such exceptional consortium partners marks a pivotal milestone for Waterfall Scientific as we advance our innovative technology,” said Dr Inna Shcherbakova, co-founder and CEO of Waterfall Scientific.
"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.
“This investment provides a truly exciting opportunity to move our promising technologies from concept to meaningful impact,” added Dr Melissa J. Moore, Waterfall Scientific co-founder.
We look forward to working with ARPA-H and our collaborators to deliver results for patients, providers and communities.
Other consortium partners include the following:
- Ansa Biotechnologies: providing rapid, high-fidelity enzymatic DNA synthesis to generate customised DNA templates for transcription.
- Volta Labs: deploying automated fluid handling and sample preparation technology to optimise and miniaturise DNA template production and characterisation
- Polymorphic Biosciences: contributing advanced LNP formulation technologies
- Tensentric: leading custom hardware design for mRNA production and fill-finish, supporting system integration and commercial prototyping for the automated manufacturing platform
- Ginkgo Bioworks: delivering system integration for manufacturing and characterisation systems and computational optimisation across the platform pipeline.
Waterfall Scientific said in a statement that the consortium hoped the resulting continuous-flow architecture would drastically reduce manufacturing footprints, lower unit costs and shorten lead times for mRNA therapeutic production from weeks to days.
In addition to emergency pandemic responses, the platform will facilitate the decentralisation of mRNA therapeutic production for targeted personalised oncology, rare disease therapies and global health interventions.
