Biotechnology, AI, and the Bioeconomy

Gene Synthesis Security

Increasing Gene Synthesis Security Risk Awareness Through Global Engagement and Collaborative Exercise Development

Mui AK, Gronvall GK, Dumaoal OSR, et al. In this case study, we describe the use of collaborative development of simulation exercises as an approach to raise awareness among key stakeholders of potential biosecurity risks associated with use of gene synthesis, while identifying context-specific, multilayered approaches to biosecurity that can be implemented at the national and institutional level. Experts from India, Indonesia, Kenya, and the Philippines worked in mentored, virtual breakout sessions to develop simulation exercises based on first-hand knowledge of local context to inform appropriate, sustainable approaches to measures to enhance oversight of nucleic acid synthesis procurement at the institutional level or to promote adoption of national frameworks. This project reinforced the proof-of-principle that collaborative exercises can be used to address a broad variety of research governance gaps to enhance national and institutional biosecurity. Health Security. 2025;23(6):449-455

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Safeguarding Mail-Order DNA Synthesis in the Age of Artificial Intelligence

Batalis S, Schuerger C, Gronvall GK, Walsh ME. Mandating mail-order DNA synthesis providers to screen DNA synthesis orders is a critical safeguarding step that should be taken as soon as possible. Over time, biological design tools will reduce the effectiveness of such a regulation and actions should be taken now to limit the negative impacts in the future. Applied Biosafety. 2024;29(2):79-84

Strengthening Security for Gene Synthesis: Recommendations for Governance.

Kobokovich A, West R, Montague M, Inglesby T, Gronvall GK. Since the inception of gene synthesis technologies, there have been concerns about possible misuse. Using gene synthesis, pathogens—particularly small viruses—may be assembled “from scratch” in the laboratory, evading the regulatory regimes many nations have in place to control unauthorized access to dangerous pathogens. Progress has been made to reduce these risks. In 2010, the US Department of Health and Human Services (HHS) published guidance for commercial gene synthesis providers that included sequence screening of the orders and customer screening. The industry-led International Gene Synthesis Consortium (IGSC) was formed in 2009 to share sequence and customer screening methods, and it now includes the major international gene synthesis providers among its members. Since the 2010 HHS Guidance was released, however, there have been changes in gene synthesis technologies and market conditions that have reduced the efficacy of these biosecurity protections, leading to questions about whether the 2010 HHS Guidance should be updated, what changes could make it more effective, and what other international governance efforts could be undertaken to reduce the risks of misuse of gene synthesis products. This article describes these conditions and recommends actions that governments should take to reduce these risks and engage other nations involved in gene synthesis research. Health Security. 2019;17(6):419-429.

California shows the way for biosecurity in commercial gene synthesis

West, R., Gronvall, G.K.

I happened to be featured in an NPR segment on gene synthesis that aired at the same time former Assemblymember Rudy Salas (CA-32) was listening. He asked his legislative aide to contact me, starting a 3-year journey, interrupted by COVID-19, to pass AB1963. This law, signed by California Governor Gavin Newsom on August 26, 2022, requires California educational institutions to only purchase gene synthesis orders from companies that perform biosecurity screening. I helped write the legislation, and testified multiple times in its support. This was the model used by the Biden Administration to enact a federal version in 2023. Nat Biotechnol38, 1021 (2020).