The goal of the NOW program is to develop a mobile medical countermeasure (MCM) manufacturing platform for use in stabilization and humanitarian operations to produce, formulate, and package hundreds of doses of nucleic acid therapeutics (DNA and/or RNA) in less than 24 hours. The developed platform should be a resilient, mobile, readily accessible nucleic acid MCM manufacturing capability that enables immediate threat response anywhere the military operates with minimal user intervention.
DARPA is soliciting innovative proposals to address the following areas: (1) novel nucleic acid synthesis methodologies; (2) automated in-line nucleic acid purification and sample analysis (QA/QC); (3) product formulation; (4) Good Manufacturing Practices (GMP) finish and fill production of the formulated product; and (5) end-to-end integration of the above component systems into a mobile platform that can produce GMP quality medical countermeasures (MCMs) in less than 24 hours. Proposed research should develop innovative approaches to: (bio)chemically generate GMP quality DNA and/or RNA therapeutic molecules within an efficient, accurate manufacturing pipeline that meets regulatory standards; in-line novel purification and product analytic tools (PAT); and automated product formulation, finish, and fill for immediate use. All components should be integrated into a final deployable platform that includes on-platform QA/QC, sequencing technology to confirm nucleic acid identity, and MCM formulation and vialing within the contained system for immediate deployment to soldiers and civilian populations. Specifically excluded is research that primarily results in incremental improvements to the existing state of practice.
Deadlines:
1. Technical Area 1 (TA1): Upstream processing. Devise novel, GMP-compatible synthesis methodologies to produce nucleic acid-based therapeutics with high efficiency and accuracy.
2. Technical Area 2 (TA2): Downstream processing and platform integration. Develop novel in-line purification and PAT. Integrate upstream and downstream processing with product formulation and fill-finish vialing into a mobile, automated end-to-end manufacturing platform that meets regulatory standards and provides an easy-to-use interface.
