Bottlenecks and opportunities for synthetic biology biosafety standards

Abstract

The lack of innovative standards for biosafety in synthetic biology is an unresolved policy gap that limits many potential applications in synthetic biology. We argue that a massive support for standardization in biosafety is required for synthetic biology to flourish.

The whack-a-mole governance challenge for AI-enabled synthetic biology: literature review and emerging frameworks

“…Newer tools, such as machine learning-based topic models, enable spotting trends across a wide set of biosafety research publications ( Guan et al, 2022 ). AI-synbio governance ( Achim and Zhang, 2022 ; Mökander et al, 2022 ; Grinbaum and Adomaitis, 2023 ; Holland et al, 2024 ) is expected to be more of the above, but also requires AI skills and perspectives that go far beyond wet lab practices and will require updates to biosafety laws, regulation, governance, standardization ( Pei et al, 2022 ). It will change the role of the state ( Djeffal et al, 2022 ) as it will no longer be the primary norm setter or enforcer of responsibility.…”

“…On the technical side, we find the challenges surrounding data quality ( Patel et al, 2009 ) the fragmentation of knowledge ( Hassoun et al, 2022 ) interoperability ( Mateu-Sanz et al, 2023 ) or standardization ( Endy, 2005 ; Hanczyc, 2020 ; Garner, 2021 ; Pei et al, 2022 ; Mateu-Sanz et al, 2023 ). For example, even though there is great need, and the desire is there, standardizing complex biological systems is difficult ( Garner, 2021 ).…”

“…Industrial challenges include: biosafety ( Pei et al, 2022 ), the availability of capital ( Baker, 2017 ; Helmy et al, 2020 ; Hodgson et al, 2022 ; Sargent et al, 2022 ), the lack of a scalable manufacturing workflow ( Hillson et al, 2019 ; Ataii et al, 2023 ), regulatory uncertainty ( Huzair, 2021 ), innovation challenges ( Banda and Huzair, 2021 ; Tait and Wield, 2021 ), intellectual property rights ( Esquivel-Sada, 2022 ), investment risks ( Hodgson et al, 2022 ), or worker safety ( Murashov et al, 2020 ).…”

“…( Endy, 2005 ; Patel et al, 2009 ; Palmer et al, 2015 ; Bauer and Bogner, 2020 ; Boyd and Wilson, 2020 ; Frow, 2020 ; Hanczyc, 2020 ; Murashov et al, 2020 ; Garner, 2021 ; Pei et al, 2022 ; Sargent et al, 2022 ; Mateu-Sanz et al, 2023 ).…”

Managing creative disturbances

“…At Biofaction, we work together with universities, research organizations, companies, and NGOs to better understand the societal ramifications of these new biotechnologies. Among others, we investigate biosafety issues (Pei et al, 2022), explore how different stakeholders see the opportunities and risks presented by these technologies, engage citizens in two-way conversations about synthetic biology, stimulate a creative process to think about the societal and environmental ramifications of synthetic biology, as part of the BIO•FICTION Science Art Film Festival for example (Schmidt et al, 2013;Youssef & Schmidt, 2020), and support the interaction between artists and scientists (Kerbe & Schmidt, 2015;Schmidt, 2018).…”