Boston — Ginkgo Bioworks has been awarded a subcontract worth up to $17.5 million under the Advanced Research Projects Agency for Health’s Genetic Medicines and Individualized Manufacturing for Everyone program to help develop an autonomous manufacturing system for individualized RNA medicines.
Ginkgo will serve as a subcontractor to Waterfall Scientific, Inc., the prime contractor for ESCALATOR, a multi-organization initiative aimed at developing a continuous-flow manufacturing system capable of producing RNA drug products at patient scale on a benchtop footprint.
The project is intended to address manufacturing challenges associated with RNA therapeutics designed for individual patients, including personalized cancer vaccines and bespoke gene therapies. Such treatments currently rely on large centralized facilities, manual workflows and quality control systems designed for much larger production batches.
ESCALATOR is being designed as a single integrated system that can accept a sequence and produce a purified, quality-released RNA drug product at the scale required for an individual patient.
The system will include four manufacturing modules covering cell-free DNA template production, RNA synthesis, lipid nanoparticle encapsulation, and fill and finish. The modules will be connected to an in-line quality control system using about 20 analytical instruments.
Ginkgo will develop the automation hardware and control software needed to integrate the system. Using its Reconfigurable Automation Carts and Catalyst software, the company plans to connect the manufacturing modules and quality control instruments through a unified robotic transport platform.
Ginkgo will also extend Catalyst to control the overall system, develop automated manufacturing and quality control protocols, support virtual protocol simulation before hardware execution, and enable automated evaluation of product quality.
“One of the most challenging parts of ESCALATOR is making instruments from six different organizations behave as one controlled, auditable system that a trained technician can operate without a robotics team standing behind them,” said Jason Kelly, co-founder and CEO of Ginkgo Bioworks. “Ginkgo has spent years building autonomous labs that can work with a variety of hardware and with proprietary software that tracks every device for every run. Distributed manufacturing has stayed a promise rather than a practice because that layer didn’t exist. We are excited to be deploying it for ESCALATOR.”
“We are thrilled to lead such an exceptional consortium on this journey to make personalized medicine a reality for patients who cannot wait. Ginkgo Bioworks brings unmatched hardware and software integration capabilities to the table, and we look forward to building a truly transformative system together,” said Inna Shcherbakova, co-founder and CEO of Waterfall Scientific.
The ESCALATOR consortium also includes Ansa Biotechnologies, Polymorphic Biosciences, Tensentric and Volta Labs. The organizations will contribute technologies ranging from DNA template production and RNA synthesis to lipid nanoparticle encapsulation, fill and finish, and manufacturing automation.
The GIVE program is administered by ARPA-H’s Scalable Solutions Office and is structured in phases covering design and engineering, system construction, integration and demonstration. Work on the project is expected to begin with a technical kickoff later this month.
The project expands Ginkgo’s work with ARPA-H and other federal agencies on healthcare manufacturing, automation and biological engineering programs.
