Journal:Next steps for access to safe, secure DNA synthesis
| Full article title | Next steps for access to safe, secure DNA synthesis |
|---|---|
| Journal | Frontiers in Bioengineering and Biotechnology |
| Author(s) | Diggans, James; Leproust, Emily |
| Author affiliation(s) | Twist Bioscience Corporation |
| Primary contact | Email: jdiggans at twistbioscience dot com |
| Editors | Morse, Stephen Allen |
| Year published | 2019 |
| Volume and issue | 7 |
| Page(s) | 86 |
| DOI | 10.3389/fbioe.2019.00086 |
| ISSN | 2296-4185 |
| Distribution license | Creative Commons Attribution 4.0 International |
| Website | https://www.frontiersin.org/articles/10.3389/fbioe.2019.00086/full |
| Download | https://www.frontiersin.org/articles/10.3389/fbioe.2019.00086/pdf (PDF) |
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Abstract
The DNA synthesis industry has, since the invention of gene-length synthesis, worked proactively to ensure synthesis is carried out securely and safely. Informed by guidance from the U.S. government, several of these companies have collaborated over the last decade to produce a set of best practices for customer and sequence screening prior to manufacture. Taken together, these practices ensure that synthetic DNA is used to advance research that is designed and intended for public benefit. With increasing scale in the industry and expanding capability in the synthetic biology toolset, it is worth revisiting current practices to evaluate additional measures to ensure the continued safety and wide availability of DNA synthesis. Here we encourage specific steps, in part derived from successes in the cybersecurity community, that can ensure synthesis screening systems stay well ahead of emerging challenges, to continue to enable responsible research advances. Gene synthesis companies, science and technology funders, policymakers, and the scientific community as a whole have a shared duty to continue to minimize risk and maximize the safety and security of DNA synthesis to further power world-changing developments in advanced biological manufacturing, agriculture, drug development, healthcare, and energy.
Keywords: biosecurity, synthetic biology, DNA, cyberbiosecurity, policy
Introduction
In 2010, the United States Department of Health and Human Services (HHS) published the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA.[1] The Guidance provided a set of recommended practices to companies synthesizing double-stranded DNA to encourage such companies to screen both their customers and requested sequences. Several of the largest DNA synthesis companies came together to form the International Gene Synthesis Consortium (IGSC), a trade industry organization intended to promote the beneficial application of gene synthesis technology while safeguarding biosecurity.
The IGSC published the Harmonized Screening Protocol[2] to provide additional tactical detail around the implementation of guidance-compliant customer and sequence screening. The IGSC guidance specifies that synthetic gene sequence orders will be screened against the IGSC's Regulated Pathogen Database (RPD), a dataset of sequences and organisms subject to regulatory control or licensing that is assembled and maintained by the IGSC. The guidance further specifies that IGSC companies will only supply genes from regulated pathogens to “bona fide government laboratories, universities, non-profit research institutions, or industrial laboratories demonstrably engaged in legitimate research.” Since its initial publication, the Harmonized Screening Protocol has been updated only once[3] to (among other minor edits) add language affirming that IGSC member companies agree not to synthesize any sequence with “best match” to Variola, the virus that causes smallpox, as the disease was declared eradicated by the WHO in 1980. Additionally, the IGSC has also developed an extensive onboarding process for potential new members to assist companies and institutions as they build new screening systems.
Acknowledgements
Author contributions
All authors listed have made a substantial, direct and intellectual contribution to the work, and approved it for publication.
Funding
This work was funded by Twist Bioscience Corporation.
Conflict of interest statement
JD and EL are employed by Twist Bioscience. Twist Bioscience is a board member of the International Gene Synthesis Consortium (IGSC). The views expressed here are not necessarily those of the IGSC.
References
- ↑ U.S. Department of Health & Human Services (4 May 2015). "Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA". https://www.phe.gov/Preparedness/legal/guidance/syndna/Pages/default.aspx.
- ↑ International Gene Synthesis Consortium (2009). "Harmonized Screening Protocol" (PDF). https://portal.sgidna.com/files/IGSC%20Harmonized%20Screening%20Protocol.pdf.
- ↑ International Gene Synthesis Consortium (19 November 2017). "Harmonized Screening Protocol v2.0" (PDF). https://genesynthesisconsortium.org/wp-content/uploads/IGSCHarmonizedProtocol11-21-17.pdf.
Notes
This presentation is faithful to the original, with only a few minor changes to presentation, grammar, and punctuation. In some cases important information was missing from the references, and that information was added. The original article listed references alphabetically; this version, by design, lists them in order of appearance.
