Field Biotechnology at Scale across the Force

Congress must direct the Department of Defense (DOD) to work with private companies to build commercial facilities across the country to biomanufacture products that are critical for DOD needs.

The private sector will not build commercial-scale biomanufacturing infrastructure for defense-related products without direction from the DOD. To address this concern, the DOD launched the Distributed Bioindustrial Manufacturing Program (DBIMP) in 2024, which supports private industry and develops commercial scale facilities that fortify defense supply chains.²⁰⁰

DBIMP targets high-risk components of the military supply chain that could be alternatively produced through biomanufacturing, such as rocket propellant, jet fuel, chemicals used for coatings on ships, and textiles for military uniforms.²⁰¹ During the program’s first phase, the DOD awarded planning grants totaling over $60 million to 34 companies. Located across the country—including in California, Nebraska, Ohio, Pennsylvania, Tennessee, and Utah—these companies are developing business and technical plans for their bioindustrial manufacturing facilities.²⁰² Importantly, through these awards, DBIMP has integrated novel companies into the nation’s defense industrial base. In the second phase, the DOD intends to award up to $100 million per company.²⁰³

DBIMP is currently funded through appropriations to Defense Production Act (DPA) Purchases, and biomanufacturing is but one of many uses of these funds.²⁰⁴ The FY25 President’s Budget requested $125 million for the “biomanufacturing of critical chemicals,” but as of December 2024, neither the House nor the Senate appropriations bills included a line item in the DPA for DBIMP.²⁰⁵ Without Congressional action, the DOD could divert DPA funds to other priorities, a move that would hollow out of the DBIMP program before it can fund full-scale biomanufacturing facilities.

Without adequate and reliable funding, DBIMP will not be able to continue de-risking projects through early-stage demonstrations nor will it be able to fund sufficient infrastructure projects. As a result, the DOD may also lose valuable partnerships. Greater risk and longer project timelines may further discourage small companies with innovative technologies from participating in these programs in the future.

Congress must support the commercialization of national security related biotechnologies by appropriating at least $762 million over the next five years to fund DBIMP. For DBIMP to succeed in the long run, the DOD must also be clear about its requirements and timelines, its communication with industry partners, and its plans for aligning industry outputs with the needs of defense purchasers. Sustained funding is critical if this program is to continue supporting and de-risking some of the nation’s most innovative companies, firms that are fielding mission-critical products and processes at the intersection of national security and emerging biotechnology.

Congress should continue oversight of and support for BioMADE’s efforts to create a network of facilities that precommercial bioindustrial companies across the country can use to meet Department of Defense (DOD) needs.

The Bioindustrial Manufacturing and Development Ecosystem (BioMADE), the DOD’s Manufacturing Innovation Institute for bioindustrial manufacturing, is a public-private partnership with nearly 300 members across 37 states, including industry leaders, academic institutions, and government officials. BioMADE’s mission is to enable domestic bioindustrial manufacturing scale-up and commercialization, develop and deploy technologies to enhance U.S. bioindustrial competitiveness, de-risk infrastructure investments, and expand the U.S. biomanufacturing workforce.²⁰⁶

BioMADE provides a promising model for supporting biotechnology companies that make up America’s defense industrial base. Its status as a public-private partnership facilitates collaboration and information sharing among industry, academia, and government. The program also works with local communities to educate and train the next generation of biomanufacturers.²⁰⁷

To support these objectives, Congress appropriated a total of $400 million in fiscal years8 2023 and 2024 for BioMADE to develop a network of open-access, precommercial bioindustrial facilities across the country.²⁰⁸ In response to Congressional appropriations, BioMADE announced several efforts to establish these facilities.²⁰⁹ As of December 2024, however, an issue of statutory interpretation is preventing BioMADE from building its first facility in Minnesota.²¹⁰ Congress—through oversight and, if necessary, statutory language—should ensure that BioMADE has the authority to spend funds on construction and that it is using those funds to construct facilities consistent with Section 215 of the FY23 National Defense Authorization Act (NDAA).²¹¹

Congress should work with the DOD to ensure that BioMADE is using previously appropriated funds effectively and quickly to establish facilities as a part of the network of precommercial facilities. It should also ensure that the DOD, the Department of Energy (DOE), and the Department of Commerce (DOC) have clear mechanisms for collaboration so that they can leverage infrastructure across agencies. If these objectives are met, Congress should consider additional appropriations in the future.

To that end, Congress should require the DOD to submit annual reports that include (at a minimum):

• the average time that it takes BioMADE to execute contracts, from the time the organization closes solicitations for a grant or contract to the time that the decision and associated funding are received;
• a list of current BioMADE awardees;
• all BioMADE grant amounts, grant purposes, execution timelines, and budgets over time; and
• an assessment of any statutory or policy hurdles to using Congressionally appropriated funds.

Congressional oversight for this initiative should include:

• site selection decisions, criteria, processes, and timelines (criteria should include discussions of operational models and completion timelines, and approval should be peer-reviewed);
• grant award decisions, criteria, processes, timelines, and communication processes for members (this selection process should also be peer-reviewed for technical feasibility by external experts);
• membership in BioMADE, what membership provides, and how membership affects usage or payment for use of the infrastructure network;
• the time it takes to add new members to the network; and
• the establishment of mechanisms for interagency participation, especially regarding DOE National Laboratories and current precommercial infrastructure.

Congress should require changes to military specifications (MIL-SPECs) to enable biotechnology companies to more easily sell their products to the Department of Defense (DOD).

Companies selling biotechnology products may not be able to sell to the DOD, as the products do not meet military specifications (MIL-SPECs), which serve as a common language that ensure military products produced by different stakeholders are functionally the same.²¹² MIL-SPECs are not intended to favor one manufacturing process over the other, but in practice, many of the specifications can be met only with traditional manufacturing. As a result, biotechnology products may be unintentionally excluded from consideration, and the DOD risks missing out on critical technologies.

To maintain its edge, the United States should make it easier for the DOD to:

• purchase biotechnology-derived products;
• adopt biotechnology-derived products; and
• maintain its technological advantage while helping the DOD fulfill its mission.

The Secretary of Defense—in consultation with the military services, the Undersecretary of Defense for Research and Engineering, the Undersecretary of Defense for Acquisition and Sustainment—should release public guidance on how nongovernment entities can prove the merit of biotechnologies and materials in meeting MIL-SPEC requirements.

To ensure that this guidance is linked to an efficient and impartial process, Congress should also task the Government Accountability Office (GAO) with conducting a comprehensive analysis of intentional or unintentional preconceptions against biotechnology and biomaterials in the MIL-SPEC process.

Lastly, standards have the greatest utility when they are adopted and applied by many stakeholders. To that end, the DOD should partner with U.S. allies to explore broader international harmonization of military specifications.

Congress should require the Department of Defense (DOD) to enter into advance market commitments (AMCs) and offtake agreements for biotechnology products that are needed for defense.

The DOD has not signaled clear and consistent demand for biotechnology products with defense applications that meet its existing needs, hindering the scale-up of these products. Instead, current DOD procurements result in fluctuating demand for emerging technologies such as biotechnology.²¹³ If companies and investors continue to doubt that there will be an end-use market in the DOD, they will not scale biotechnology products needed for defense.

Advance market commitments (AMCs) and offtake agreements would send a strong DOD demand signal for biotechnology products, overcoming the uncertainty in year-to-year demand that results from differences in the DOD’s annual appropriations. There are a number of biotechnology products that could meet the DOD’s needs. For example, the DOD could use biobased concrete to build runways or landing pads or bioremediation technologies to break down PFAS in water or soil on military instillations.²¹⁴ Already, the DOD has identified a list of critical chemicals that may require domestic production due to vulnerabilities in the supply chain, many of which could be biomanufactured domestically.²¹⁵

Congress should direct the DOD to use its other transaction authorities (OTAs) to establish AMCs for biotechnology products that would be produced at scale in the United States, meet the DOD’s technical needs, and are competitive on cost, schedule, and performance. Congress should also direct the DOD to establish a pilot program to award offtake agreements to biotechnology companies.

For AMCs, the Undersecretary of Defense for Acquisition and Sustainment should:

• first define which DOD technical needs can be met with biotechnologies such as biobased concrete, bioremediation products, and biobased chemicals;
• design AMCs to include agreed-on product prices, specifications, delivery timelines, and criteria for evaluation;
• design AMCs in consultation with technical and market experts from inside and outside the DOD;
• exercise OTAs to establish and implement AMCs;
• report to Congress annually on the progress and success of AMCs; and
• use lessons learned to develop and report to Congress a strategy for how AMCs and other innovative financial tools could be used to procure biotechnology products that meet U.S. national security needs.

For offtake agreements, the Undersecretary of Defense for Acquisition and Sustainment should:

• exercise OTAs to create a pilot Biotechnology Purchase Incentive Program to award prizes in the form of offtake agreements to biotechnology companies for products that meet the DOD’s technical needs, laying out agreed-on prices, specifications, delivery timelines, and criteria of evaluation; and
• report annually to Congress on the progress and success of the program for oversight purposes and for its possible extension.

Congress should require the Department of Defense (DOD) and other agencies involved in national security to train their workforces to be ready for biotechnology.

New technologies and concepts in biotechnology are constantly emerging, and biotechnology is increasingly converging with other emerging technologies, including AI and quantum. The DOD and intelligence community (IC) workforce must maintain an up-to-date understanding of critical and emerging technologies to effectively execute national security policy. To maximize effectiveness, these efforts should reach into the military services and include the Joint Staff and combatant commands.

Keeping the government’s biotechnology training up-to-date is especially critical given the fast pace of advances. (For more recommendations on equipping the U.S. government with necessary biotechnology resources and expertise, see Section 5.1.) Currently, however, there are limited opportunities for federal employees working on national security to upskill in biotechnology.

The DOD, the IC, and other agencies with national security mandates should upskill their workforces in biotechnology and biosecurity through tailored training. Such training would help the U.S. government maintain improved threat awareness and give employees the up-to-date knowledge they need to make informed decisions about funding and using biotechnology.

Specifically, Congress should require that:

• relevant parts of the DOD and the IC define core competencies for their biotechnology and biodefense personnel, including outlining requirements for refresher training on the latest advances in biotechnology science, laboratory work, equipment, and software (these requirements should be informed by core competencies defined by relevant agencies, such as the U.S. Department of Agriculture (USDA) and the Department of Health and Human Services (HHS) (see Section 5.1b));
• the DOD develop workforce education and training on biotechnology for both uniformed and civilian personnel whose duties involve analyzing, preparing for, or responding to biological threats;
• the Office of the Director of National Intelligence (ODNI) provide educational courses at the National Intelligence University (NIU) or other venues to ensure that intelligence professionals covering biotechnology have a functional understanding of how the field is advancing; and
• the Department of Homeland Security (DHS)—including Customs and Border Protection (CBP), Homeland Security Investigations (HSI), and the Transportation Security Administration (TSA)—as well as the Federal Bureau of Investigation (FBI), develop workforce education and training on biotechnology issues, particularly for personnel who might encounter inbound and outbound biological samples or who focus on issues related to illicit technology transfer.

NASEM Report on Research and Development in Biotechnology for Defense Innovation 

In addition to the extensive outreach that the Commission conducted with external stakeholders, the Commission contracted with the National Academies of Sciences, Engineering, and Medicine (NASEM) to assess the risks and rewards of biotechnology research and development (R&D), with particular focus on its convergence with artificial intelligence (AI) and automation.ˡ

Through a series of workshops and a final report, this work emphasized the promise of biotechnology converging with other technology areas, including recent breakthroughs and future innovations.ˡⁱ The NASEM report lays out a strategic vision for optimizing research and innovation at the intersection of AI, automation, and biotechnology by connecting and coordinating key elements of these technologies, including robotics, data, compute, and algorithms.

Many of their conclusions and recommendations are reflected in the recommendations throughout the Commission’s own report, showing important alignment of priorities between stakeholders in different sectors.

In their main recommendation, NASEM calls for the creation of the Biotechnology Coupled with Artificial Intelligence and Transformative Automation for Laboratory Yielding Strategic Technologies (BioCATALYST) network. Led by the Department of Defense (DOD) and the Office of the Director of National Intelligence (ODNI), this network would leverage academic institutions, industry, and government to use emerging technologies to address national security challenges. This network would involve generating AI-ready datasets, establishing pilot test beds for technology demonstration, identifying technology transition partners in industry, establishing a research program on ethical and societal questions, and creating a program for robust risk assessments. 

The NASEM and Commission reports share the common thread of recognizing the great potential of biotechnology for national security and the importance of taking action now to turn this potential into reality. The NASEM’s report is available here.