The past year has been an exciting time for the bioeconomy as U.S. government agencies work to update their approaches and improve coordination to better support bio-based products and processes. Action within the government has been spurred by a September 2022 Executive Order on Advancing Biotechnology and Biomanufacturing Innovation and by the CHIPS and Science Act signed into law in August 2022. The Federation of American Scientists (FAS) received a grant to support policy development for the bioeconomy, and has worked to generate discussion and ideas that the government could pursue. In December, 2022, we conducted two multi-stakeholder, discussion-based bioeconomy policy workshops focused on Measurement and Language and on Financial and Economic Tools. We have also worked with outside experts to publish policy memos with specific ideas, including ways to improve coordination across the government and an approach for investing in biomanufacturing facilities.
As U.S. government agencies consider how to support the bioeconomy, it will be important to pay attention to industry perspectives on key hurdles, market failures, and ways the federal government could work to address those challenges. To better understand these perspectives, FAS conducted interviews with representatives from eight private sector companies that develop biotechnology capabilities and products. These companies pursue a wide range of different types of biomanufacturing, including: cell-free synthesis of biochemicals; fermentation for compounds that are high-value and low-volume; fermentation for compounds that are low-value and high-volume; and cellular and tissue culture. They also conduct business in a variety of bioeconomy sectors, including fuels, fragrances, specialty chemicals, pharmaceuticals, and biologics. Many are smaller, less established companies that are familiar with the challenges that the industry faces as opportunities and investment in the bioeconomy increase. Collectively, they represent a new generation of biotechnology companies that are expanding the possibilities for biotechnology products and biomanufacturing.
Key points and ideas from industry interviews
Building biomanufacturing physical infrastructure. Every interviewee believed that biomanufacturing infrastructure for scale-up and production was lacking in the U.S. Additional capacity is needed for many types of biomanufacturing; from fermentation to cell and tissue culture. Interviewees also said this applies at all stages of production, from pilot-scale to intermediate-scale to large-scale. One interviewee noted that the capacity crunch is particularly difficult for small companies, which sometimes will have to “beg” for fermentation time from larger companies who have better access to facilities.
Addressing pre-competitive challenges in the bioeconomy. Government funding of basic research is essential, but there is also a need for specific funding for biomanufacturing science. Multiple interviewees mentioned the Advanced Biofuels and Bioproducts Process Development Unit (ABPDU), the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), and BioMADE as good investments for the federal government (though they also said that contracting and collaborating with these institutes can be difficult). Interviewees also believed that the federal government should work to develop standards for biomanufacturing processes and facilities, and that biodata infrastructure (e.g., Genbank) should be updated, modernized, and secured.
Ensuring the US government is a good financial partner. The federal government can sometimes provide good funding opportunities, but these opportunities are often inflexible and procedurally burdensome for applicants. Interviewees believed that government funding should be indirect, where possible, and that loans should include terms that allow long repayment timelines because many biomanufacturing investments take a long time to achieve sustainable revenues.
Developing a bioeconomy workforce. Multiple interviewees noted that it was difficult to find people with training in fermentation and other biomanufacturing processes, and that this type of training, including access to facilities, should be included in graduate school programs. Public-private partnerships that include academia and industry could facilitate these opportunities. Also, visa processes should be updated so that non-Americans with training in biomanufacturing or process engineering could be more easily hired.
Building incentives and removing barriers for bio-based products and processes. Interviewees came up with multiple ideas for how the US government could improve incentives and remove barriers for the bioeconomy, including: better identifying and prioritizing sustainable products and processes; updating the biotechnology regulatory system; updating the renewable fuel standards at EPA to accommodate new approaches; and improving incentives for bio-based government procurement (the Biopreferred Program is a good start, but needs to be revisited and expanded). Interviewees also believed that supply chain mapping of resources and products that support the bioeconomy would demonstrate vulnerabilities and increase incentives for investment in more secure, U.S.-based facilities.
Although the companies chosen for these interviews represent different business models, biotechnologies, and perspectives, common themes emerged regarding the challenges companies face and potential solutions to address them. In particular, every interviewee noted the need for biomanufacturing facilities at many scales and for many different types of applications. The industry representatives also had suggestions for how the U.S. government could help address pre-competitive issues in the bioeconomy (such as standards-setting and advancing biomanufacturing science) and ways that it could become a better financial partner for private companies. Other ideas included ways that federal agencies could support development of the bioeconomy workforce and could work to improve incentives for bio-based products and processes. As the bioeconomy advances, it will be important to ensure that industry voices continue to be included in policy development discussions.
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