Nucleic acids On-demand Worldwide (NOW) will allow for rapid and distributed manufacturing of nucleic acid-based medical countermeasures
Feb 4, 2021
The U.S. military routinely deploys throughout the world where warfighters can potentially be exposed to regional endemic diseases as well as chemical, biological, radiological, or nuclear (CBRN) threats. Rapid access to medical countermeasures (MCMs) against these threats is critical to protect Defense Department (DoD) personnel and local populations; however, manufacturing, stockpiling, and distribution issues remain.
To address these challenges, DARPA has established the Nucleic acids On-demand Worldwide (NOW) program to develop a mobile MCM manufacturing platform to rapidly produce, formulate, and package hundreds of doses of nucleic acid therapeutics in days – rather than months or years. The system promises to provide significant advancement over current cell-based methods, and the resulting product could allow for end-to-end synthesis of Good Manufacturing Practice (GMP) quality material, even in austere environments. The mobile nature of the NOW platform aims to provide immediate threat response anywhere the military operates, mitigate surprise from infectious disease threats, and ensure a resilient, readily accessible nucleic acid MCM manufacturing pipeline.
“This mobile manufacturing system is designed to fit into a CONEX box and taken ‘on the go’ for stabilization and humanitarian missions in addition to traditional military operations,” noted Dr. Amy Jenkins, NOW program manager. “The ability to manufacture therapeutics on-site is a huge advantage in time to produce a product and reduction in logistical burden.”
The NOW program will be organized into three phases. In the 36-month Phase 1, performers will investigate new bio/chemical methods to synthesize nucleic acids (Technical Area 1), and explore downstream purification, analysis, and formulation of newly synthesized material (Technical Area 2). A 12-month Phase 2 will focus on system integration to finalize a contained, end-to-end mobile manufacturing platform. In coordination with the U.S. FDA, the 12-month Phase 3 will focus on a human clinical study that directly compares a NOW-derived product with traditionally-manufactured material. This will demonstrate full platform functionality while producing an MCM targeting a DoD relevant disease indication.
Contracts have been awarded to Moderna, Inc. and GE Research to advance the goals of the program.
“These teams are well positioned to combine the novel approaches to nucleic acid cell free synthesis and the required system engineering approaches for a distributed manufacturing system to ensure the NOW program requirements are met,” noted Jenkins. “Upon program completion, the NOW platform could have important commercial applications by providing increased MCM production and manufacturing during periods of high demand.”
Additional details of the program schedule and metrics are available in the 2019 broad agency announcement at https://beta.sam.gov/opp/012d635117004012a37295c2b10ff78f/view#general.
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