DOD Publishes Biomanufacturing Strategy and RFI on Biomanufactured Products and Process Capabilities

By Lynn L. Bergeson and Carla N. Hutton
 
As part of the National Biotechnology and Biomanufacturing Initiative, the U.S. Department of Defense (DOD) announced in September 2022 an investment of $1.2 billion in bioindustrial domestic manufacturing infrastructure to catalyze the establishment of a domestic bioindustrial manufacturing base accessible to U.S. innovators. As reported in our March 30, 2023, blog item, on March 22, 2023, DOD released its Biomanufacturing Strategy to guide these investments, and its broader efforts in this critical technology field. According to the Biomanufacturing Strategy, as commercial use of new technologies expands, if the United States fails to invest in its domestic manufacturing capabilities, market forces could drive manufacturing overseas, often at the expense of the national economy and potentially creating vulnerabilities in the DOD supply of these products.
 
The Biomanufacturing Strategy is focused around three core principles:

• Establish DOD transition partners for early-stage innovations: Establishing DOD customers for biomanufactured capabilities will guide DOD technology investments. The core of the DOD Biomanufacturing Strategy is a culture shift throughout DOD that both recognizes and prioritizes, where applicable, biotechnology-based solutions to prevent strategic surprise.
• Develop the field of biomanufacturing through innovations in practice and application; According to the Biomanufacturing Strategy, research is required in scaling-up biomanufacturing to produce at a scale sufficient to prototype these products. The Biomanufacturing Strategy states although this is a hurdle in adopting biotechnology-based solutions to DOD mission needs, “it is also an incredible opportunity to develop biomanufacturing at home and with allies and partners to create a self-sustaining domestic biomanufacturing ecosystem.” It will also contribute to the United States remaining the “world leader in innovation,” guarantee DOD interests are protected, and ensure that U.S. global competitiveness in biotechnology is maintained.
• Map the domestic biomanufacturing ecosystem and the changes that occur over time for identification and tracking of metrics to support future implementation and refinement of the biomanufacturing strategy: According to the Biomanufacturing Strategy, for DOD to build enduring advantage through the implementation of the Biomanufacturing Strategy, DOD needs to address implementation risk. Concurrent with DOD’s need to prioritize where it places its resources in biomanufacturing, DOD “will support an upfront assessment of the biomanufacturing ecosystem, along with continued evaluation during and following early investments, allowing for more precise tailoring” of DOD resource allocation as the biomanufacturing ecosystem develops. The Biomanufacturing Strategy states that mapping the biomanufacturing ecosystem and establishing metrics to evaluate the bioeconomy “is central to mitigating implementation risk.”

In support of the Biomanufacturing Strategy, DOD issued a formal request for information (RFI) on biomanufactured products and process capabilities that could help address defense needs and whose development and commercialization could be addressed by DOD investment. The intent of the RFI is to gather information about U.S. national security industrial base shortcomings, risks, and opportunities that may be addressed by investments made under the provisions in Title III of the Defense Production Act (DPA). According to the RFI, biomanufactured products of interest include those that “enable capabilities within the following application and operational spaces of interest, and will bring revolutionary changes to military capabilities, the operations environment, and supply chain resiliency.” Such application and operational spaces may include, but are not necessarily limited to:

• Manufacture specialty chemicals and materials that are needed by DOD in an available and affordable manner (e.g., biomanufactured fuels and energetic precursors, biosynthetic fibers such as but not limited to spider silk, polymers, natural rubber/latex rubber, solvents);
• Enable reduced logistic costs, time, and energy through bio-composite and living materials (e.g., tunable materials with enhanced properties, self-healing materials);
• Maintain persistent sensing capabilities for sustained human and environmental intelligence (e.g., sensors for water quality monitoring, biobased energy harvesting in maritime systems);
• Augment human systems by impacting performance and protection (e.g., tailored proteins, but specifically excluding biopharma and probiotics); and
• Enable manufacturing defense relevant materials in a manner to reduce the impact on the environment while meeting or exceeding product performance requirements.

Responses are due by April 19, 2023, at 12:00 p.m. (EDT). The RFI notes that if late information is received, the government reviewers may consider it, depending on agency time constraints.