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Review
. 2024 Sep 18;29(3):123-132.
doi: 10.1089/apb.2024.0005. eCollection 2024 Sep.

Biosecurity Assessments for Emerging Transdisciplinary Biotechnologies: Revisiting Biodefense in an Age of Synthetic Biology

Diane DiEuliis  1 , Michael J Imperiale  2 , Kavita M Berger  3
Affiliations
Review

Biosecurity Assessments for Emerging Transdisciplinary Biotechnologies: Revisiting Biodefense in an Age of Synthetic Biology

Diane DiEuliis et al. Appl Biosaf. .

Abstract

Introduction: Rapid advances in biotechnologies and transdisciplinary research are enhancing the ability to perform full-scale engineering of biology, contributing to worldwide efforts to create bioengineered plants, medicines, and commodities, which promise sustainability and innovative properties.

Objective: This rapidly evolving biotechnology landscape is prompting focused scrutiny on biosecurity frameworks in place to mitigate harmful exploitation of biotechnology by state and non-state actors. Concerns about biosafety and biosecurity of engineering biology research have existed for decades as views about how advances in this and associated fields might provide new capabilities to malicious actors. This article considers biosecurity concerns using examples of research advances in engineering biology.

Methods: The authors explore risk assessment and mitigation of transdisciplinary biotechnology research and development, using the framework developed in the National Academies' study on Biodefense in an Age of Synthetic Biology.

Results: The Synthetic Biology Assessment Framework focuses on risks of using advanced approaches and technologies to enhance or create novel pathogens and toxins. The field of engineering biology continues to advance at a pace that challenges current risk assessment frameworks.

Conclusions: This framework likely is sufficient to assess new science and technology advances affecting conventional biological agents. However, the risk assessment framework may have limited applicability for technologies that are not usable with conventional biological agents and result in economic or broader national security concerns. Finally, the vast majority of discourse has been focused primarily on risks rather than benefits, and analyzing both in future evaluations is critical to balancing scientific progress with risk reduction.

Keywords: biohybrid; biological security; engineering biology; generative artificial intelligence; microbiome; synthetic biology.

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Figures

Figure 1.
Figure 1.
Framework for assessing concern. Source: National Academies of Sciences, Engineering, and Medicine.
See this image and copyright information in PMC

References

    1. Cello J, Paul AV, Wimmer E. Chemical synthesis of poliovirus cDNA: Generation of infectious virus in the absence of natural template. Science 2002;297(5583):1016–1018; doi: 10.1126/science.1072266 - DOI - PubMed
    1. Gibson DG, Glass JI, Lartigue C, et al. . Creation of a bacterial cell controlled by a chemically synthesized genome. Science 2010;329(5987):52–56; doi: 10.1126/science.1190719 - DOI - PubMed
    1. Hutchison CA 3rd, Chuang RY, Noskov VN, et al. . Design and synthesis of a minimal bacterial genome. Science 2016;351(6280):aad6253; doi: 10.1126/science.aad6253. Erratum in: ACS Chem Biol 2016;11(5):1463. - PubMed
    1. Cyranoski, D. The CRISPR-baby scandal: What's next for human gene-editing. Nature 2019;566(7745):440–443. - PubMed
    1. National Academies of Sciences, Engineering, and Medicine. Second International Summit on Human Genome Editing: Continuing the Global Discussion: Proceedings of a Workshop–in Brief. The National Academies Press: Washington, DC, USA; 2010; doi: 10.17226/25343 - DOI - PubMed

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