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KEY TAKEAWAYS

•   Biotechnology is poised to emerge 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 US government is still working to grasp the scale of this bio-opportunity and has relied too heavily on private-sector investment to support the foundational technology innovation needed to unlock and sustain progress.

•   Biotechnology is one of the most important areas of technological competition between the United States and China, and China is investing considerably more resources. Lacking equivalent efforts domestically, the United States runs the risk of Sputnik-like strategic surprises in biotechnology.

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Overview

Biotechnology partners with biology to create products and services, like 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-specifi ed 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 fi eld 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 cells to be programmed 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. This 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. 

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 the potential for biology to be recognized as a general-purpose technology that could become the foundation of a more resilient manufacturing base. 

Biological large language models (BioLLMs) Large language models (LLMs), which are a form of artificial intelligence, have emerged that 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.

 

Over the Horizon

To fully realize biology as a technology, improving biotechnology methods is essential. Advancing tools for measuring, modeling, and creating with biology offers a chance for global leadership. Similarly, streamlining and coordinating biotechnology workflows and commercialization can cement this position. Identifying gaps in national portfolios, such as the need for standards and reference materials to support a networked bioeconomy, is critical for strategic development.

The 2022 US federal strategic vision for biotechnology, including various initiatives and commissions, primarily focuses on applications and outcomes. However, these initiatives also provide opportunities to support foundational bioengineering research. Active multilateral efforts are needed to seize these chances through advice and input.

“Patient capital,” both private and public, is crucial for foundational research, since many biotechnologies have long development timelines. Such long-term capital must be sustained in times of ebb and flow in the pace of scientific advancement. For example, although mRNA vaccines gained widespread public attention in 2021, their history began thirty years ago.

From a strategic perspective, four areas of significant consequence and opportunity need to be tracked: (1) progress toward constructing life from scratch (e.g., building a cell); (2) advances in electrobiosynthesis (i.e., growing biomass starting from renewable electricity and atmospheric carbon); (3) advances in next-generation DNA synthesis; and (4) progress toward profitability (i.e., when synthetic biology companies realize and sustain significant profits).

POLICY, LEGAL & REGULATORY ISSUES

Environmental and Safety Risks 

Bioengineered organisms raise concerns about their potential impact on natural and human environments. For instance, bioengineered organisms that escape into the environment and possibly disrupt local food chains or natural species have long been an issue. Governments could improve public understanding of these risks and their management. Importantly, synthetic biology offers the potential to create organisms incapable of escaping or evolving, potentially addressing some of these concerns. 

National Security and Public Safety Considerations 

As the science and technology of synthetic biology become increasingly available to state and nonstate entities, legitimate fears arise 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. The United States faces the challenge of maximizing biotechnology benefits while minimizing risks of misuse. In response, the National Security Commission on Emerging Biotechnology (NSCEB) and a Department of Defense task force have been established. Both are expected to produce significant reports during 2025, complementing ongoing Executive Office activities in shaping biotechnology policy and security measures. 

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. A Wilson Center report notes that 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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