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KEY TAKEAWAYS

•   Biotechnology is emerging as a general-purpose technology by which anything bioengineers learn to encode in DNA can be grown whenever and wherever needed— essentially enabling the production of a wide range of products through biological processes across multiple sectors.

•   The United States is still not executing well on strategies for emerging biotechnology and has relied too heavily on private-sector investment to support foundational work needed to scale and sustain progress.

•   Biotechnology is one of the most important areas of technological competition between the United States and China, and China is now leveraging two decades of strategic investment to secure global leadership. Absent swift and ambitious actions, the United States risks biotechnological surprise and a loss of biotechnology sovereignty.

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Overview

Biotechnology partners with biology to create products and services, such as engineering skin microbes to fight cancer or brewing medicines from yeast. This industry, already 5 percent of US GDP, is poised for significant growth. Synthetic biology, a subset of biotechnology focusing on enhancing living systems, relies on DNA sequencing and synthesis. DNA sequencers are machines that read or decode specific DNA molecules, while synthesizers write user-specified sequences of DNA. Rapid progress in these technologies is driving innovation and expanding biotechnology’s potential applications. 

Biology as a manufacturing process is distributed—leaves do not come from a central production facility but rather grow on trees everywhere. However, commercial biotechnology has become centralized and capital intensive. This contrast suggests a potential paradigm shift toward a more distributed approach in biotechnology, aligning it more closely with nature’s decentralized production model. 

Synthetic biology merges biology, engineering, and computer science to modify and create living systems, developing novel biological functions served by amino acids, proteins, and cells not found in nature. This field creates reusable biological “parts,” streamlining design processes and reducing the need to start from scratch, thus advancing biotechnology’s capabilities and efficiency. 

Synthetic biology has applications in medicine, agriculture, manufacturing, and sustainability. DNA and RNA synthesis underlies all mRNA vaccines, including those for COVID-19. Synthetic biology can also cultivate drought-resistant crops and enable the programming of cells to manufacture medicines or fuel on an agile, distributed basis.

 

Key Developments 

Distributed Biomanufacturing This offers unprecedented production flexibility in both location and timing. Fermentation production sites can be established anywhere with access to sugar and electricity. The approach enables swift responses to sudden demands like disease outbreaks requiring specific medications. Such adaptability revolutionizes manufacturing, making it more efficient and responsive to urgent needs.

Biological Computing Computing has become central to modern biology. For example, artificial intelligence (AI) methods accelerate research by enabling the computational exploration of protein behavior, significantly reducing (though not eliminating) the need for expensive laboratory experiments. Large language models (LLMs), a form of AI, are being trained on natural DNA, RNA, and protein sequences. Called BioLLMs, they can generate new biologically significant sequences that are helpful points of departure for designing useful proteins. Models and software can be used to generate promising drug designs that may be able to speed up drug discovery from months or years to weeks.

 

Over the Horizon

Routinization of Cellular-Scale Engineering Today, most of biotechnology operates through trial-and-error “design-build-test-learn” cycles that rely on expert labor and extensive experimentation. A transformative alternative is emerging that involves constructing cells entirely from defined chemical components. Progress in synthetic cell creation promises systems capable of autonomous growth and evolution, enabling routine, analysis-driven engineering—or “design-buildwork”— at the cellular level. Achieving this routinization would mark a Sputnik-like moment for biotechnology, freeing bioengineering from natural constraints and enabling scalable, reliable design of new biological systems unconstrained by Earth’s evolutionary lineages. 

Electrobiosynthesis Photosynthesis is a natural process that captures atmospheric carbon dioxide to make organic molecules vital for life. Electrobiosynthesis (eBio) is an emerging approach that uses electricity to do the same. This method, potentially powered by solar energy, could be far more landefficient than traditional agriculture. Early successes highlight eBio’s potential to produce biomolecules sustainably, reduce land and water use, and enable biomanufacturing in challenging environments. 

Tissue Printing Tissue printing uses living cells as “inks” to build tissue-like structures that may be employed to fabricate natural organs. Producing billions of specialized cells via bioreactors supports scaling toward implant-ready tissues. Tissue printing is advancing from simple cell sheets to vascularized, functional, and viable tissues, moving whole-organ fabrication from the realm of theory toward engineering reality.

Biology as a General-Purpose Technology Currently, biotechnology is used to make medicines, foods, and a narrow range of sustainable materials. But anything whose synthesis can be encoded in DNA could be grown. For example, some bacteria are capable of growing arrays of tiny magnets, and select sea sponges grow glass filaments similar to human-made fiber-optic cables. These and other examples suggest potential for the recognition of biology as a general-purpose technology that could become the foundation of a more resilient manufacturing base.

POLICY ISSUES

National Security and Public Safety Considerations 

Legitimate fears have arisen that malicious actors will create organisms harmful to people and the environment. For example, polio, horsepox, SARS-CoV-2, and influenza have been synthesized from scratch in laboratories. Bioengineered organisms that escape into the environment and may disrupt local food chains or natural species have long been an issue. Importantly, synthetic biology offers the potential to create organisms incapable of escaping or evolving, potentially addressing some of these concerns. 

Mirror life—consisting of organisms made from molecules that are mirror images of natural biomolecules, such as left-handed DNA instead of the natural right-handed DNA—is a more recent concern. While mirror life is possibly useful for certain kinds of drug development, concern over the risk of a release of mirror microorganisms that could evade detection from the immune system and cause serious ecological and health risks has prompted calls for strict regulation or bans on their creation. 

Geopolitical Considerations 

China is rapidly outpacing the United States and Europe in biotechnology, as highlighted by China’s nearly 350 top-cited synthetic biology papers published in 2023, compared to 41 from the United States. Additionally, China-based firms have seen a twentyfold increase in novel drug licensing deals over the past decade. Without a strong, coordinated response from the United States and Europe to China’s all-ofnation biotech strategy, the West risks losing leadership in biotechnology innovation and manufacturing. 

Ethical Considerations 

Different religions may have varying views on engineering new life-forms and whether this violates their principles. These concerns, often classified as nonphysical impacts on innovation, are challenging to predict. Such issues involve potential harm to deeply held beliefs about what is right or good, including humans’ relationship with themselves and nature.

 

REPORT PREVIEW: Biotechnology Synthetic Biology

Faculty Council Advisor

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Drew Endy
Author
Drew Endy

Drew Endy is the Martin Family University Fellow in Undergraduate Education (bioengineering), codirector of degree programs for the Hasso Plattner Institute of Design (the d.school), core faculty at the Center for International Security and Cooperation (CISAC), and senior fellow (courtesy) of the Hoover Institution at Stanford University. He serves as president and director of the Biobricks Foundation and director of the iGEM Foundation and the Biobuilder Educational Foundation. His research focuses on the foundations of synthetic biology along with broader societal aspects. He earned a PhD in biotechnology and biochemical engineering from Dartmouth College.

View Bio
drew-endy_profilephoto.jpg
Drew Endy

Drew Endy is the Martin Family University Fellow in Undergraduate Education (bioengineering), codirector of degree programs for the Hasso Plattner Institute of Design (the d.school), core faculty at the Center for International Security and Cooperation (CISAC), and senior fellow (courtesy) of the Hoover Institution at Stanford University. He serves as president and director of the Biobricks Foundation and director of the iGEM Foundation and the Biobuilder Educational Foundation. His research focuses on the foundations of synthetic biology along with broader societal aspects. He earned a PhD in biotechnology and biochemical engineering from Dartmouth College.

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