Nucleic Acids On-Demand Worldwide

With a renewed emphasis on stabilization efforts, the Department of Defense (DoD) is in constant need of field-forward technologies that allow production of materiel when and where it is needed. Because of cold chain requirements and the breadth, diversity, and unknown nature of the biological/chemical threat, one of the most logistically difficult materials to provide during stabilization missions are therapeutics. The goal of the NOW program is to develop a mobile medical countermeasure (MCM) manufacturing platform for use in stabilization and humanitarian operations to rapidly produce, formulate, and package hundreds doses of nucleic acid therapeutics (DNA and/or RNA). In order for an adaptable nucleic acid manufacturing platform to rapidly develop and deploy pure, sequence-accurate MCMs in days instead of months to years, new fundamental biochemical or chemical synthesis methods are needed. Further, fielding an end-to-end platform capable of leveraging those new (bio)chemistries with minimal operator training or expertise will require additional innovation to develop rapid in-line analytics and MCM processing. The NOW program will develop new technical capabilities to address these gaps, including: (1) devising new (bio)chemistries that enhance the efficiency, accuracy, and pace of nucleic acid synthesis; (2) devising an automated GMP quality nucleic acid manufacturing pipeline that meets regulatory standards; and (3) developing in-line novel purification and analytic tools.

The mobile nature of the NOW platform will provide immediate threat response anywhere the military operates, mitigate surprise from disease threats, and ensure a resilient, readily accessible nucleic acid MCM manufacturing pipeline.