The Bioprocess International (BPI) meeting kicked off on Tuesday morning with an opening plenary session led by Sarah Glaven, PhD, principal assistant director of biotechnology and biomanufacturing at the White House Office of Science and Technology Policy. In the talk, she outlined the strategies defined in the Biden administration’s Executive Order on Advancing Biotechnology and Biomanufacturing Innovation, the progress over the past few years, and the future directions for the project.
She stated that it is “so critically important that we have the highest levels of government engaged on this topic.”
Biomanufacturing is an extremely precise form of chemistry, she noted, that can transform carbon and other inputs into products. And our ability to precisely program biology, she added, has accelerated over the past several decades.
Everything that we need, she said, is already available above ground. We can make the products that we use every day from biomass. We can convert sugar, using a biological system, into anything that we need: fuel, plastic, food, etc. And there is the possibility to create new materials with never-before-seen properties that cannot currently be achieved.
Biomanufacturing is part of a sustainable manufacturing strategy for the future. And that is why the Biden/Harris administration has included it in their broader, industrial, strategy.
So, what has been holding biomanufacturing back? Glaven offered a few reasons: biotech is “a nascent field” despite the huge advances that have been made, costs are still relatively high compared to other products (such as petroleum products versus jet fuel from plants), and logistics are challenging. There is not a coordinated network of biomanufacturing that allows easy movement through the stages of the research and commercialization pipeline. There are expensive, costly, logistical challenges, such as shipping samples back and forth around the world.
How does the Biden/Harris administration view their role in making change? Biotechnology is saving lives; one need look no further than the work done through the COVID-19 pandemic and also examples like gene therapies that are coming online. There will be an increased need to feed more people in the future, such as fermenting high nutrient-dense proteins and food materials, or creating more drought-resistant and heat-tolerant crops. We also need non-food crops that will generate the raw materials to feed biomanufacturing processes. And the chemicals industry is also changing, with a customer-driven requirement for more sustainable products.
“It’s a combination of the recognition of the importance of biotechnology and biomanufacturing,” Glaven stated, “and the recognition that the industry at large is so nascent. In order to grow a bioeconomy, we need a whole government strategy.”
Two years ago, in September 2022, Biden signed an executive order to advance biotech and biomanufacturing innovation for a sustainable, safe, and secure American bioeconomy. It is a broad initiative that calls to stimulate innovative solutions across many sectors: health, climate change, energy, agriculture, food security, supply chain, and economic security, with the principles of equity, ethics, safety, and security.
The goal is to advance science in the United States, reduce obstacles to commercialization, and enable products to reach markets faster.
What has the executive order accomplished in the past two years?
Some investments that have been made are: the Department of Defense has taken the lead in expanding bio-industrial manufacturing in multiple areas—they have completed awards for providing resources to 25 different biotech companies to develop business plans that would demonstrate that their technology is ready to scale to a commercial level. There will be $100 million given next year to build those out.
The Department of Energy has given awards for sustainable aviation fuel, many of which have been done through the Inflation Reduction Act. Alongside those grant challenges is the technology being invested in our rural communities to support refining feedstocks going into biomanufacturing.
The NSF is investing in the earlier stage R&D end of the spectrum, giving $75 million to support the biofoundry initiatives that will help innovate in academia and early-stage partners.
In June, the National Security Council announced a coalition between the U.S., U.K., EU, Republic of Korea, and India—the Bio 5 coalition—to ensure that we are working together to ensure the security and safety of biopharma supply chains.
The key target of the investments coming out of biotech and biomanufacturing is to address bridging the gap between R&D and commercialization.
Our goal, Glaven said, is to make sure that we don’t have tech and innovation dying off when it leaves the laboratory. We need to pilot and scale those technologies and get them where they are ready to go to the commercial level.
In the future, they want to create a distributed network that will enable growth, she asserted.
Recently, a National Bioeconomy Board made up of 12 departments and agencies was formed to implement the executive order and formalize policy initiatives. It’s new and they are working on how to formalize it. But it will act to try to maintain consistency through changes during the election cycle.
They are focused on improving and expanding domestic biomanufacturing production capacity and processes. They want to promote standards, establish metrics, and develop systems to grow and assess the state of the bioeconomy with international partners. They also work to clarify and streamline biotech regulations where possible.
In the future, they plan to invent and innovate, create products that meet customer expectations for supply chain diversification and sustainability as they scale, and make sure that the government bolsters a favorable business environment through government procurement and the regulatory environment, and ensure safety and security during the digital transformation. Lastly, they want to foster collaboration and innovation and ways in which industry and academia can bridge the entire spectrum from development and commercializing pipeline and take advantage of this moment!
