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Synthetic Biology: Revolutionizing Industries, Navigating Science Frontiers

Ethical oversight and regulatory coordination challenge advances in harnessing life.

A microbiologist at a U.S. Army lab employs insect antennae to identify chemicals in an area. Credit: Sophia Espinosa, U.S. Army

Synthetic biology holds promise but requires careful oversight to ensure that its development causes minimal to no harm, according to experts.

This discipline aims to apply engineering principles to biology, akin to how electrical engineering uses precise tools like capacitors and resistors. This discipline envisions cells as “factories,” capable of producing materials traditionally made by fossil-fuel-driven industrial processes. A prime example is biomanufacturing, where cells are harnessed to create products such as pharmaceuticals, biofuels and high-value materials, including those used in cosmetics and clothing, according to Nina Dudnik, senior commercialization advisor at the Noble Reach Foundation.

“Our industrial revolution idea of manufacturing is an enormous factory powered by fossil fuels and this idea of a biomanufacturing system, where your real factory is, is individual cells,” Dudnik illustrated.

Synthetic biology’s role in future development is promising because it has the potential to revolutionize various industries by enabling advancements in areas such as medicine, agriculture, defense and environmental sustainability. It offers opportunities to create innovative solutions, like developing disease-resistant crops or new therapeutic treatments. However, it also presents significant ethical, ecological and security challenges that require careful oversight to ensure the technology is used responsibly.

“You’ve got to reach that happy medium between providing enough policy and regulation, but without impeding the progress in the technology area,” said Brian Bothwell, director of engineering and technology assessment at the U.S. Government Accountability Office (GAO), a legislative watchdog.

One key to leveraging these organisms for desirable results is around carbon dioxide capture from industrial emissions. This gas can be used to feed microbes, which then produce materials for various industries, such as textiles and biofuels.

Researchers are working toward finding the best candidates in this budding field.

“Among prospective industrial production cells, mainly bacteria and yeasts are being proposed as chassis cells for upcoming synthetic biology applications as they can use various feedstocks from a wide range of sources,” according to Simone Bachleitner, postdoctoral research fellow at the University of Natural Resources and Life Sciences, Vienna, Austria.

Financial growth is expected in the sector, predicting the market could expand tenfold to $100 billion by 2030. While research has increased since 2008, and several commercial products have emerged, the technology remains largely in an experimental phase, with widespread commercial applications still on the horizon, according to Bothwell.

This field is challenged by the difficulty of scaling up production efficiently. Dudnik noted that while small-scale, high-cost production is feasible, the field has yet to make the leap to large-scale, affordable production.

“The component parts of genetics and cells end up interacting with their environment in ways that we cannot predict, so it’s become sort of complicated, but the core dream still persists, and it’s gotten much, much more complex,” Dudnik said.

According to Dudnik, this limitation is one of the primary focus areas of current research, with efforts aimed at making processes like biofuel production more efficient and cost competitive.

Most products in the market have a limited economic footprint. “They’re still in a research or clinical mode; they are not out there for commercial or widespread use yet,” Bothwell explained.

Dudnik underscored synthetic biology’s sustainability potential, particularly its ability to repurpose waste materials as feedstock for decentralized biomanufacturing. This innovation could drastically reduce the carbon footprint of production processes while offering critical solutions for both military and civilian sectors.

Microbes could produce drugs or vaccines on-site, particularly in remote or combat environments.

“In a sort of last-mile solution, being able to diagnose [warfighters] in the field and then generate there, in small quantities, using either cellular or cell-free manufacturing, the exact therapeutic that they need,” Dudnik told SIGNAL Media in an interview.

This technology for low-scale production at the point of care is easier to develop and deploy and adds value.

“The military is often first responders in humanitarian situations around the world, so these solutions have a lot of dual purposes as well,” Dudnik explained.

The intersection of AI and biology is another growing field, where large language models are being trained on DNA and protein sequences.

“You could use individual molecules of DNA to store way more information in a much, much smaller footprint,” said Dudnik, an expert in technology translation and entrepreneurship in biology.

This technology could eventually design new enzymes and proteins that do not naturally exist, offering breakthroughs in bioengineering. However, Dudnik also raised concerns about the ethical implications of removing humans from the decision-making process in AI-driven laboratories.

Researchers supervise activities in molecular biology at the Naval Medical Research Center, in Bethesda, Maryland. Credit: Phil Collins, U.S. Navy

The Congressional Research Service, a legislative agency, weighed in on this topic and produced guidelines for regulation.

Policy drafting recommendations include “keeping a human ‘in the loop,’ controlling access to DNA sequences and synthesis capabilities, and governance mechanisms that restrict, or monitor, who can access certain AI applications and biological design tools,” according to a report.

Bothwell highlighted three policy recommendations from his GAO report. First, policymakers should improve access to scientific expertise to guide decisions effectively. Second, enhanced coordination among domestic and international stakeholders is essential to address the ethical and ecological challenges posed by advances like gene editing. Finally, the report calls for reviewing and possibly updating current regulatory frameworks to strike a balance between fostering innovation in synthetic biology and ensuring responsible, ethical use without compromising U.S. competitiveness in the field. The author emphasized the importance of this dialogue to avoid either stifling innovation or allowing unchecked development.

“Policymakers really need to be talking to the smart people who are doing this work, understand this work, are doing research in this area, so that they make good decisions,” Bothwell said.

The second recommendation calls for enhanced coordination between domestic and international stakeholders. Harnessing biology presents ethical and ecological risks, particularly in areas like human gene editing. Bothwell warned that while modifying plant DNA might seem benign, human gene manipulation could have unforeseen and potentially dangerous consequences.

“There are some things you could do with human gene DNA and human genes that are really kind of going into almost a mad scientist area where, maybe, we shouldn’t go and that’s part of what we’re calling for with that coordination,” Bothwell told SIGNAL Media in an interview.

A separate GAO report, “Considerations for Maintaining U.S. Competitiveness in Quantum Computing, Synthetic Biology, and Other Potentially Transformational Research Areas,” suggested that enhancing coordination among research agencies in synthetic biology requires a strategic approach that includes developing formal mechanisms for collaboration, such as consortia. This would ensure that expertise and resources are pooled effectively, helping to advance research while avoiding duplication of efforts.

Nevertheless, it criticizes the lack of effective mechanisms for coordination among research agencies in synthetic biology, with multiple agencies involved in research. There is insufficient formal collaboration, leading to duplication of efforts and missed opportunities for leveraging resources. This report stressed the need for a cohesive strategy to promote cross-agency partnerships, which would improve research efficiency and help address the complex challenges associated with synthetic biology advancements.

To enhance coordination among regulatory agencies, the report recommends clearer roles and responsibilities across agencies and the establishment of unified goals. This coordination would help streamline regulatory processes, ensuring that emerging synthetic biology technologies are managed responsibly without stifling innovation.

Additionally, Bothwell stressed the need for a balanced regulatory framework that fosters innovation while maintaining ethical standards. He likened this to other emerging technologies, such as artificial intelligence, where the challenge lies in determining whether existing regulations are adequate or if new ones are necessary. He suggested that, for now, the GAO’s role is to ask questions and prompt discussion, rather than offering concrete policy solutions.