Scientists are getting closer to something that once sounded like science fiction: building the basic components of life from scratch.
Known as synthetic cells, these lab-designed systems aren’t fully alive, but they can mimic key behaviors of living cells, like producing molecules or responding to their environment. In the future, they could be used to deliver medicine, detect environmental hazards or help crops grow more efficiently.
But as the science advances, so do the questions.
How do you regulate something that sits between chemistry and life? What happens if these systems move beyond the lab? And how do researchers balance potential benefits with unknown risks?
A new report from the National Academies of Sciences, Engineering and Medicine examines those questions, focusing on the biosafety, biosecurity and environmental considerations of synthetic cell research.
Felicia Wu, a Michigan State University John A. Hannah Distinguished Professor and internationally recognized expert in risk analysis and biotechnology policy, serves as co-chair of the National Academies committee helping lead a cross-disciplinary group of scientists, engineers and policy experts to evaluate how these emerging technologies should be governed as they continue to evolve.
In this “Ask the Expert,” Wu explains what synthetic cells are, what they could be used for and why building the rules around them may be just as important as building the technology itself.
For people who may not be familiar, what exactly are synthetic cells?
Synthetic cells are encapsulated cell-like systems built from biomolecular components that perform one or more life-like processes, such as metabolism, information processing, or self-organization. Importantly, they span a very wide range of complexity. At one end are simple biochemical assemblies that do not replicate and at the other are genome-containing systems that may be capable of growth and replication. There is no single, universally accepted definition. That ambiguity isn’t just a scientific issue; it directly affects governance because definitions shape how systems are classified and regulated.
Why is there so much attention on synthetic cells right now? What’s changed? What could synthetic cells be used for in the real world?
Biotechnology has been advancing rapidly in the past several years, as well as increasingly moving from laboratories into diverse real-world applications: agriculture, medicine, public health, infrastructure such as buildings and roads, and manufacturing. Examples that we give in our report are synthetic cells used for environmental remediation, for crop nutrient delivery in agriculture, and for targeted medical delivery of therapies in the body.
The idea of synthetic cells is not new. For decades if not centuries, scientists have been interested in whether it would ever be possible for humans to create these basic building blocks of life. But today, the biotechnologies to create synthetic cells are more readily available and accessible than ever.
What are the biggest risks or concerns when it comes to synthetic cells?
Concerns are different depending on the state of development and the type of synthetic cells. Can they replicate? How can replication be appropriately contained so that there is no risk in the relevant environment (lab, ecosystem, etc.)? How long do they persist in their intended, or unintended, environments? Are there unforeseen risks, particularly in potential interactions with living systems?
These are not risks unique to synthetic cells, but fairly common across new technologies, especially biotechnologies. That is why appropriate governance structures at the level of laboratories and institutions early in synthetic cell research and development, to federal agencies later when synthetic cells may be deployed, are so important.
What’s the biggest challenge in regulating or overseeing synthetic cells today?
There are two challenges. The first is that regulatory oversight is distributed across many institutions and differs depending on the state of synthetic cell development. The second is that synthetic cells can be applied in so many different ways that there may not necessarily be one appropriate template for regulation across all synthetic cells. Rather, regulation must be conducted on a case-by-case basis.
What are the most important recommendations from the report?
Our key recommendations are the formation of a National Biotechnology Governance Strategy, strengthening the evidence base for benefits and risks associated with different synthetic cell types and applications, implementing an adaptive framework for benefit-cost and risk analyses, enabling effective governance, modernizing biosafety and biosecurity oversight, and advancing responsible innovation and public engagement.
Why are public trust and transparency so important as this field develops?
Public trust and transparency in communication are so important because the public will ultimately be at the receiving end of synthetic cell applications. Ideally for good — especially if applications improve the quality and effectiveness of medicine as well as agricultural and manufacturing production — but potential costs and risks must be assessed and communicated thoroughly.
You served as co-chair of this National Academies report. Why were you asked to help lead this effort, and what perspective did you bring to the committee?
This report is the result of a congressional mandate to assess the environmental, biosafety and biosecurity considerations of synthetic cells research and development. The National Science Foundation sponsored the U.S. National Academies to form a committee to perform this assessment.
National Academies program officers first approached me in 2024 to ask if I would be willing to serve on this committee, at that time to co-lead a report with a focus on the ethical, legal and social implications of engineering biology. They knew of my decades of work in agricultural biotechnology, both research and policymaking — going back to my Ph.D. work since the 1990s on the risks and benefits of transgenic Bt corn (a GMO, or genetically modified organism), including its reduction of mycotoxins such as aflatoxin. I’d also had the chance to work at the Environmental Protection Agency when we did the benefit-risk assessment and registration of Bt crops in 2001 and have continued work in this area ever since, including USDA grants and a recent publication in Science on this topic.
What role can universities like Michigan State play in advancing this work responsibly?
So many MSU colleges and institutes have important expertise to lend to the field of synthetic cells and their responsible research, deployment and communication with the public. This field spans basic biology and chemistry, engineering, biotechnology and application areas in agriculture, human medicine, veterinary medicine, and beyond. Philosophical considerations of ethics, particularly bioethics, and communication arts and sciences are critical in responsible innovation in this space and in communication with the public about the technology’s uses.
