By Lynn L. Bergeson and Carla N. Hutton
 
On August 29, 2023, the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced that through the funding opportunity entitled “Accelerating Innovations in Biomanufacturing Approaches through Collaboration Between [the U.S. National Science Foundation (NSF)] and the DOE BETO funded Agile BioFoundry (ABF),” researchers will collaborate with the ABF consortium’s synthetic and bioengineering research projects. BETO and NSF have selected the following projects:

• Enabling Scalable Redox Reactions in Biomanufacturing (University of California, Irvine, and University of California, Davis): This project will enhance the carbon and energy efficiency of a biomanufacturing process by upgrading carboxylic acids into precursors for biofuels and chemicals used in industry. The goal is to create a more efficient process for carboxylic acid reduction that does not release any carbon into the atmosphere. The team will work to identify the principles necessary to enhance efficiency in the enzymes used in the process. Through outreach efforts, the researchers will provide hands-on exposure to science, technology, engineering, and math (STEM) fields for largely Hispanic populations and women, both groups underrepresented in science and engineering.
   
• A Synthetic Biology Toolbox for Studying Bacterial Transporters (University of Wisconsin -- Madison): This project will develop and use tools to close knowledge gaps surrounding transporters in Gram negative bacteria to facilitate the development of superior biomanufacturing hosts. Specifically, they will work to identify proteins that enhance the uptake of nutrients into the cells of microbes and the removal of toxic products. The work will enable the development of superior biomanufacturing microbial hosts and support translational research. Activities that teach biomanufacturing concepts to K-8 students and recruitment of underrepresented researchers will broaden the impacts of the work.
   
• Leveraging the Unique Metabolism of Megasphaera elsdenii for Metabolic Engineering to Medium and Long Chain Organic Acids for Use in Jet Fuels and Biomaterials (University of Georgia): The project will work to increase understanding of the metabolic pathways that allow the microorganism Megasphaera elsdenii to produce hexanoic acid, that can be engineered to create sustainable aviation fuel among a host of other products. Understanding how octanoic acid is created in this organism will enable scientists better to convert plant sugars to longer chain molecules and will provide paths for alternative approaches to bioprocessing. The team will recruit students from underrepresented groups and create classroom resources for use in elementary schools.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy (DOE) Bioenergy Technologies Office (BETO) announced on July 17, 2023, that it will host a Bioenergy Cybersecurity Workshop, a virtual event organized by Sandia National Laboratories on September 11, 2023, to identify cybersecurity risks in biofuel and bioproduct manufacturing, and develop an approach to address these risks. According to BETO, the workshop will raise awareness of the importance of cybersecurity in biomanufacturing safety, operational continuity, and competitiveness. It will consist of panel presentations by bioprocessing and cybersecurity experts. Participants will discuss the state of biofuel and bioproduct cybersecurity practices, and the security of biobased processes to help identify and define cybersecurity technologies and research needed for cybersecure bioenergy production. Workshop objectives will include:

• Exploring the risks and potential consequences to biofuel and bioproduct production that stem from cybersecurity vulnerabilities;
• Discussing the state of practice in biofuel and bioproduct cybersecurity;
• Gathering stakeholder input on what research and development is needed to fill capability gaps in cybersecurity for bioenergy facilities; and
• Building connections across the bioenergy cybersecurity community.

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By Lynn L. Bergeson and Carla N. Hutton
 
On June 30, 2023, EuropaBio announced that it “set[] in stone the first European recommendations on biomanufacturing with the publication of its Biomanufacturing Policy Summit 2023 report.” On March 15, 2023, EuropaBio hosted its inaugural Biomanufacturing Policy Summit in Brussels, “marking the first major milestone from its newly established Biomanufacturing Platform.” The Summit captured priorities of 80 industry leaders, policy makers, and stakeholders to highlight the crucial role of cross-sectoral biomanufacturing for Europe’s future. The recommendations include:

• Recognizing cross-sectoral biomanufacturing within high-level European strategies, such as the European Union (EU) Industrial Strategy, Pharma Strategy, Bioeconomy Strategy, and Green Deal Industrial Plan;
• Creating targets for increasing biomanufacturing within the EU economy, supported by policy strategies that identify and recognize its economic, social, and environmental contributions across sectors;
• Coordinating at a policy level the alignment between research and development (R&D) focus, industrial priorities, and commercial applications toward delivering sustainable products and processes through biomanufacturing;
• Recognizing and addressing critical points and vulnerabilities within biomanufacturing value chains to improve European competitiveness;
• Aligning legislation to address unintentional barriers to biomanufacturing scale up for Europe;
• Positioning regulatory frameworks and resources for product rather than process-driven criteria to increase agility and accelerate Europe’s green transition;
• Recognizing Europe’s improved resilience resulting from biomanufacturing capacity for healthcare preparedness and supply chain resilience across sectors;
• Supporting the uptake of European innovation converted into value-added businesses and economic development and incentivizing investment into start-ups and small- and medium-sized enterprises (SME) to scale-up biomanufacturing within Europe;
• Creating a skills pathway for biomanufacturing and advanced manufacturing to ensure access to critical re-skilling and up-skilling in all European countries; and
• Ensuring a global level playing field for transition to sustainable biomanufacturing processes and products.

According to EuropaBio, the recommendations from the Summit will underpin its growth of the Biomanufacturing Platform, working with industry across sectors to ensure that it receives the visibility and recognition required.

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By Lynn L. Bergeson and Carla N. Hutton
 
On June 27, 2023, the Office of Science and Technology Policy (OSTP) announced the release of a new action plan intended to “rapidly and equitably expand biotechnology and biomanufacturing education and job training programs in the United States.” According to OSTP, biomanufacturing “is a critical aspect of advanced manufacturing that can drive new, sustainable alternatives across industries” and “can unlock new solutions in health, climate change, clean energy, food security, agriculture, supply chain resilience, and national and economic security.” OSTP states that the action plan will help propel continued investment in the bioeconomy and maintain America’s leadership in this sector by preparing more Americans for these jobs and build a diverse pipeline that includes women, people of color, people living in rural communities, and others underrepresented in emerging fields.
 
The action plan includes the following core recommendations, along with select new and ongoing actions that the Biden Administration is taking and will take -- in collaboration with employers, unions; state, local, and Tribal governments; high schools; institutions of higher education; industry associations; and other stakeholders:

• Expand and diversify the talent pool for biotechnology and biomanufacturing jobs and careers to promote innovation and advance equity;
• Strengthen worker-centered sector strategies and other partnerships between employers, labor organizations, community colleges, and other training providers to grow and diversify the bioworkforce;
• Develop and rigorously evaluate innovative approaches to education and training for biotechnology and biomanufacturing jobs and careers, scaling and promoting those found to be most effective;
• Partner with state, local, and Tribal governments, education and training providers, bioscience associations, unions and other worker-serving organizations, and other stakeholders to raise awareness about the promise and potential of careers in the bioworkforce; and
• Improve data and analytic capacity and cross-sector collaboration to advance equity and support effective workforce development -- including the development of industry-recognized credentials and competency models.

According to OSTP, the Biden Administration is already beginning to implement the action plan by taking the following actions:

• The National Science Foundation (NSF), the U.S. Department of Energy (DOE), and the U.S. Department of Agriculture (USDA) will take action to expand partnerships with Historically Black Colleges and Universities (HBCU), Tribal Colleges and Universities (TCU), and Minority Serving Institutions (MSI);
• The U.S. Department of Education will create cross-sector collaborations through the Unlocking Career Success Initiative and launch a professional learning series focused on bioworkforce needs and the role of K-12 schools and postsecondary institutions;
• The U.S. Department of Labor (DOL) is prioritizing advanced manufacturing, including biomanufacturing, in key grant programs, such as the State Apprenticeship Expansion Formula grant;
• The U.S. Department of Commerce (DOC) will support a National Institute for Innovation in Manufacturing Biopharmaceuticals pilot program designed to attract high school students into biopharmaceutical manufacturing career pathways; and
• NSF, in partnership with DOL, DOC, and other agencies, will convene a forum to build alignment on recognized competency models, development of new competency models where needed, and exploration of credentialing mechanisms for the bioworkforce.

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By Lynn L. Bergeson and Carla N. Hutton
 
The Office of Management and Budget (OMB) published a request for information (RFI) on April 27, 2023, seeking public input on existing or potential bioeconomy-related industries and products that are established, emerging, or currently embedded in existing industry/manufacturing processes. 88 Fed. Reg. 25711. As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” Under the EO, the Chief Statistician of the United States (CSOTUS) in OMB’s Office of Information and Regulatory Affairs (OIRA) was charged with improving and enhancing federal statistical data collection designed to characterize and measure the economic value of the U.S. bioeconomy. The CSOTUS was also charged with establishing an Interagency Technical Working Group (Working Group) to recommend bioeconomy-related revisions for the North American Industry Classification System (NAICS) and the North American Product Classification System (NAPCS). OMB states that the bioeconomy refers to a segment of the total economy utilizing or derived from biological resources and includes manufacturing processes, technologies, products, and services. These may encompass, wholly or in part, industries and products including fuel, food, medicine, chemicals, and technology. To ensure consideration of comments on potential bioeconomy-related industries and products solicited in the RFI, OMB asked that all comments be submitted “as soon as possible,” but no later than June 12, 2023.
 
The Working Group, through OMB, seeks input on how to identify, classify, and measure best bioeconomy manufacturing, technology, and products, including those that are primarily or exclusively: (a) biobased, (b) components of traditional manufacturing processes, and (c) nascent biobased processes and products. Importantly, according to OMB, input should include information on how particular industries or products are linked to the bioeconomy and, where appropriate and available, evidence should be provided. OMB states that this will afford the Working Group the opportunity to use existing evidence to inform its recommendations. The RFI includes the following questions:

• What information and what high-priority concerns should the Working Group consider in making these recommendations for potential revisions to the NAICS and NAPCS that would enable characterization of the economic value of the U.S. bioeconomy?
   
• Which quantitative economic indicators and processes are currently used to measure the contributions of the U.S. bioeconomy? Are these indicators reasonably accurate measures of the product components, scope, and value of the bioeconomy? Please explain why.
   
• Which industries not currently measured as unique classifications in NAICS related to the bioeconomy should be considered? Similarly, which products not currently measured as unique classifications in NAPCS related to the bioeconomy should be considered? Please describe how a unique classification for such industry or product would meet the principles of NAICS and NAPCS. Please include a description of the industry or product, with specific examples. Please also provide an explanation of how such industry or product would advance understanding of measuring the bioeconomy.
   
• How might potential changes to the NAICS impact existing industry measurements, such as assessing changes in the economic output across current industries, time series measures, or data accuracy?
   
• What role can the NAPCS fill in order to advance measurement of biomanufacturing and biotechnology?
   
• Biobased processes and products that are embedded in traditional industries pose challenges for differentiation and measurement. Are there methodologies that can differentiate these bioeconomy processes from current manufacturing processes to enable measurement? If yes, please explain.
   
• What potential bioeconomy measurement strategies might be considered other than revisions to and inclusion in the NAICS or NAPCS? For example, are there ways the federal government could better collect information to provide better measurement on biobased processes or products in current industries?

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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.

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By Lynn L. Bergeson and Carla N. Hutton

As reported in our March 30, 2023, blog item, on March 22, 2023, the White House Office of Science and Technology Policy (OSTP) released a new report, Bold Goals for U.S. Biotechnology and Biomanufacturing: Harnessing Research and Development to Further Societal Goals. The report includes five sections, each presenting goals that highlight what could be possible with the power of biology. The goals set ambitious national targets for the next two decades to help establish research and development (R&D) priorities that will be critical to advance the bioeconomy. Each section also outlines the essential R&D needed to achieve these goals for the U.S. bioeconomy, opportunities for public-private collaboration, and recommendations for enhancing biosafety and biosecurity. The report notes that achieving these goals will require significant prioritization of R&D investments and other efforts across the U.S. government, as well as actions from the private sector; state, local, and Tribal governments; and international partners.
 
The report states that bold goals for the U.S. bioeconomy include, for example:

• Climate: In 20 years, demonstrate and deploy cost-effective and sustainable routes to convert biobased feedstocks into recyclable-by-design polymers that can displace more than 90 percent of today’s plastics and other commercial polymers at scale;
• Food and Agriculture: By 2030, reduce methane emissions from agriculture, including by increasing biogas capture and utilization from manure management systems, reducing methane from ruminant livestock, and reducing methane emissions from food waste in landfills, to support the U.S. goal of reducing greenhouse gas (GHG) emissions by 50 percent and the global goal of reducing methane emissions by 30 percent;
• Supply Chain: In 20 years, produce at least 30 percent of the U.S. chemical demand via sustainable and cost-effective biomanufacturing pathways;
• Health: In 20 years, increase the manufacturing scale of cell-based therapies to expand access, decrease health inequities, and decrease the manufacturing cost of cell-based therapies tenfold; and
• Cross-Cutting Advances: In five years, sequence the genomes of one million microbial species and understand the function of at least 80 percent of the newly discovered genes.

According to this report, reaching these goals will require progress in other areas beyond R&D to ensure that innovation can lead to safe, effective, and equitable products that will grow the bioeconomy. The report states that in forthcoming reports and plans, departments and agencies will outline recommendations and steps that are underway to advance the following:

• Data for the bioeconomy -- Establishing a Data Initiative to ensure that high-quality, wide-ranging, easily accessible, and secure biological data sets can drive breakthroughs for the U.S. bioeconomy;
• Domestic biomanufacturing infrastructure -- Expanding domestic capacity to manufacture all the biotechnology products invented in the United States and to support a resilient supply chain;
• Workforce development -- Growing training and educational opportunities for the biotechnology and biomanufacturing workforce of the future;
• Regulatory clarity and efficiency -- Improving the clarity and efficiency of the regulatory process for biotechnology products to help ensure products come to market safely and efficiently;
• Biosafety and biosecurity -- Creating a Biosafety and Biosecurity Innovation Initiative to reduce risks associated with advances in biotechnology and biomanufacturing; and
• International engagement R&D -- Pursuing cooperation through joint research projects and data sharing, while mitigating risks and reaffirming democratic values.

According to the report, OSTP will lead the development of a strategy and implementation plan to execute on R&D priorities and other actions identified in the report.

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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our September 13, 2022, blog item, President Joseph Biden signed an Executive Order (EO) on September 12, 2022, creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” On March 22, 2023, the White House Office of Science and Technology Policy (OSTP) published a fact sheet announcing “new bold goals and priorities that will catalyze action inside and outside of government to advance American biotechnology and biomanufacturing”:

• Harnessing Biotechnology and Biomanufacturing Research and Development (R&D) to Further Societal Goals: On March 22, 2023, OSTP released a new report, Bold Goals for U.S. Biotechnology and Biomanufacturing: Harnessing Research and Development to Further Societal Goals, outlining a vision for what is possible with the power of biotechnology and biomanufacturing and the R&D needs to achieve this ambitious vision. Biden’s EO called on federal departments and agencies to assess the potential for biotechnology and biomanufacturing R&D to further five societal goals: climate change solutions; food and agricultural innovation; supply chain resilience; human health; and crosscutting advances. The report includes individual sections authored by the Department of Energy (DOE), the U.S. Department of Agriculture (USDA), the Department of Commerce (DOC), the Department of Health and Human Services (DHHS), and the National Science Foundation (NSF), in consultation with other agencies and departments, that are responsive to the President’s EO. The goals and R&D needs outlined in the report serve as a guide for public- and private-sector efforts to harness the full potential and power of biotechnology and biomanufacturing to develop innovative solutions in different sectors, create jobs at home, build stronger supply chains, lower costs for families, and achieve our climate goals. According to the fact sheet, OSTP will now lead the development of an implementation plan to address the R&D needs outlined in the report.
   
• Establishing Biomanufacturing Priorities for DOD: As part of the National Biotechnology and Biomanufacturing Initiative, 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. On March 22, 2023, DOD released its Biomanufacturing Strategy to guide these investments, and its broader efforts in this critical technology field. This strategy, which will guide research efforts and collaboration with the private sector and allies, sets three key priorities: establishing the customers within DOD that stand to benefit from early-stage innovations, advancing biomanufacturing capabilities through innovation, and mapping the biomanufacturing ecosystem and tracking metrics that support future efforts. In support of the strategy, DOD issued a formal request for information on biomanufactured products and process capabilities that could help address defense needs and whose development and commercialization could be addressed by DOD investment.
   
• Assessing the Economic Value of the Nation’s Bioeconomy: DOC’s Bureau of Economic Analysis released a new report that assesses the feasibility of measuring the economic contributions of the U.S. bioeconomy. The report also includes an assessment of what is needed to measure these contributions better and more accurately.

According to the fact sheet, other deliverables from the EO are in development, including: a plan to expand training and education opportunities for the biotechnology and biomanufacturing workforce, a report on data needs for the bioeconomy, a national strategy for expanding domestic biomanufacturing capacity, actions to improve biotechnology regulation clarity and efficiency, and a plan for strengthening and innovating biosafety and biosecurity for the bioeconomy.

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By Lynn L. Bergeson and Carla N. Hutton
 
That National Academies of Sciences, Engineering, and Medicine (NASEM) hosted an October 2022 workshop on successes and challenges in biomanufacturing. The workshop brought together biomanufacturing stakeholders across industry, academia, and government with expertise across diverse fields, including United States-based and international speakers. According to NASEM, discussions spanned the breadth of biomanufacturing contexts and applications, including bioindustrial and biopharmaceutical manufacturing. NASEM’s Proceedings of a Workshop-in Brief provides a high-level summary of the topics addressed at the workshop. Topics covered include:

• Biomanufacturing for Sustainability and a Circular Bioeconomy;
• Regulation and Standards;
• Biomanufacturing Workforce Development and Education;
• Economic Considerations and Challenges in Biomanufacturing;
• Biomanufacturing Ecosystems and Partnerships;
• Translating Lessons from Different Biomanufacturing Sectors;
• Modeling, Data, Analysis, and Process Control;
• Biomanufacturing Platform Development; and
• Biomanufacturing Infrastructure and Tools for Scaling.

NASEM notes that the summary should not be viewed as consensus conclusions or recommendations of NASEM.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) recently announced the selection of five external collaborations totaling over $3.7 million to conduct research and development (R&D) needed to accelerate the U.S. biomanufacturing sector. Working with scientists at the Agile BioFoundry (ABF) consortium, these industry and academic groups will leverage national laboratory capabilities to address challenges in biomanufacturing. The projects include:

• University of California, Berkeley will address the pressing need for a scalable method for double-stranded ribonucleic acid (RNA) production for agricultural pesticide applications, employing microbial strain engineering and fermentation scale-up;
• Birch Biosciences will develop improved technologies that enable engineering of high-performance enzymes for economical and sustainable plastic recycling;
• Kiverdi will develop a platform for sequestering carbon dioxide to produce secreted recombinant proteins;
• University of Nebraska-Lincoln will expand the synthetic biology biosensor toolkit for Methanosarcina, a promising archaeal host organism that can be used to create fuels and renewable chemicals; and
• Azolla will leverage ABF’s capabilities to engineer a bacterium capable of using sunlight and carbon dioxide to produce nanocellulosic fiber to replace current unsustainable production practices in the textile industry.

The selected projects all directly contribute to producing renewable biofuels and biobased chemicals and materials. They also help ABF build foundational technologies critical for the decarbonization of the industrial and transportation sectors. Funded by BETO, ABF aims to advance biomanufacturing by uniting and expanding the capabilities of the national laboratories.

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