Synthetic Biology: Biosecurity and Biosafety Implications

  • Gigi Kwik GronvallEmail author


Synthetic biology and other advanced biotechnologies hold a great deal of promise for medicine, public health, manufacturing, and national economies, but they also have biosafety and biosecurity implications. Using synthetic biology techniques, it is possible for a nefarious actor to acquire a viral pathogen made with chemically synthesized pieces, versus having to acquire samples of pathogens from an environmental source or from another laboratory. It is also possible to test many parallel approaches for designing new functions into existing pathogens, given that the costs of DNA synthesis continue to drop; this has dual-use implications for biodefense. These biosecurity concerns do not replace the existent challenges prior to the advent of synthetic biology but add to them, as early non-synthetic biology paths to biological weapons development are still able to be used to make biological weapons. In addition to biosecurity concerns, there are biosafety implications of synthetic biology, as the techniques are powerful, they may be used outside of traditional biocontainment, and because relative newcomers to biological containment are entering the field.


Synthetic biology Biosafety Dual-use research of concern Biosecurity 


  1. 1.
    Synthetic Biology Project. What is synthetic biology? Woodrow Wilson International Center for Scholars. Accessed 31 Jan 2018.Google Scholar
  2. 2.
    Doudna JA, Charpentier E. Genome editing. The new frontier of genome engineering with CRISPR-Cas9. Science. 2014;346(6213):1258096.CrossRefGoogle Scholar
  3. 3.
    Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT ACT) Act of 2001, §Sec. 817. Expansion of the biological weapons statute. 2001.Google Scholar
  4. 4.
    Federal Select Agent Program. Select agents and toxins list. 2017. Accessed 31 Jan 2018.
  5. 5.
    The Australia Group. Common control lists. 2017. Accessed 16 July 2017.
  6. 6.
    Rambhia KJ, Ribner AS, Gronvall GK. Everywhere you look: select agent pathogens. Biosecur Bioterror. 2011;9(1):69–71.CrossRefGoogle Scholar
  7. 7.
    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):1016–8.CrossRefGoogle Scholar
  8. 8.
    Wimmer E. The test-tube synthesis of a chemical called poliovirus. The simple synthesis of a virus has far-reaching societal implications. EMBO Rep. 2006;7(Spec No S3):3–S9.Google Scholar
  9. 9.
    Smith HO, Hutchison CA 3rd, Pfannkoch C, Venter JC. Generating a synthetic genome by whole genome assembly: phiX174 bacteriophage from synthetic oligonucleotides. Proc Natl Acad Sci USA. 2003;100(26):15440–5.CrossRefGoogle Scholar
  10. 10.
    Tumpey TM, Basler CF, Aguilar PV, et al. Characterization of the reconstructed 1918 Spanish influenza pandemic virus. Science. 2005;310(5745):77–80.CrossRefGoogle Scholar
  11. 11.
    Noyce RS, Lederman S, Evans DH. Construction of an infectious horsepox virus vaccine from chemically synthesized DNA fragments. PLoS One. 2018;13(1):e0188453.CrossRefGoogle Scholar
  12. 12.
    Koblentz GD. The de novo synthesis of horsepox virus: implications for biosecurity and recommendations for preventing the reemergence of smallpox. Health Secur. 2017;15(6):620–8.CrossRefGoogle Scholar
  13. 13.
    Inglesby T. Important questions global health and science leaders should be asking in the wake of horsepox synthesis. The Bifurcated Needle; 2017.Google Scholar
  14. 14.
    DiEuliis D, Berger K, Gronvall G. Biosecurity implications for the synthesis of horsepox, an Orthopoxvirus. Health Secur. 2017;15(6):629–37.CrossRefGoogle Scholar
  15. 15.
    Hutchison CA, Chuang R-Y, Noskov VN, et al. Design and synthesis of a minimal bacterial genome. Science. 2016;(6280):351.Google Scholar
  16. 16.
    Venter JC, Gibson D. How we created the first synthetic cell. The Wall Street Journal; 2010, May 26 (Opinion).Google Scholar
  17. 17.
    J Craig Venter Institute. First self-replicating synthetic bacterial cell frequently asked questions. 2010. Accessed 4 Oct 2013.
  18. 18.
    Pollack A. His corporate strategy: the scientific method. NY Times. 2010;5:BU1.Google Scholar
  19. 19.
    US Department of Health and Human Services. Screening framework guidance for providers of synthetic double-stranded DNA. Fed Regist. 2010;75(197):62820–32.Google Scholar
  20. 20.
    International Gene Synthesis Consortium (ICSC). Harmonized screening protocol: gene sequence & customer screening to promote biosecurity. 2009.Google Scholar
  21. 21.
    International Gene Synthesis Consortium. International gene synthesis consortium updates screening protocols for synthetic DNA products and service. 2018, January 3.Google Scholar
  22. 22.
    Carter SR, Friedman RM. DNA synthesis and biosecurity: lessons learned and options for the future. San Diego: J. Craig Venter Institute; 2015.Google Scholar
  23. 23.
    Dieuliis D, Carter SR, Gronvall GK. Options for synthetic DNA order screening, revisited. mSphere. 2017;2(4)Google Scholar
  24. 24.
    National Academies of Sciences E, Medicine. A proposed framework for identifying potential biodefense vulnerabilities posed by synthetic biology: interim report. 2017.Google Scholar
  25. 25.
    Church G. De-extinction is a good idea. Scientific American; 2013.Google Scholar
  26. 26.
    Cai Y, Agmon N, Choi WJ, et al. Intrinsic biocontainment: multiplex genome safeguards combine transcriptional and recombinational control of essential yeast genes. Proc Natl Acad Sci USA. 2015;112(6):1803–8.CrossRefGoogle Scholar
  27. 27.
    Wade N. Synthetic bacterial genome takes over a cell, researchers report. NY Times; 2010, May 20, A17(L).Google Scholar
  28. 28.
    Grant B. News in a nutshell. Scientist; 2011.Google Scholar
  29. 29.
    J. Craig Venter Institute. Press release: first self-replicating synthetic bacterial cell. 2010, May 20.Google Scholar
  30. 30. web page. Accessed 22 Feb 2016.
  31. 31.
    Zayner J. Learn science by doing. 2016. Accessed 25 Mar 2016.
  32. 32.
    Baltimore Under Ground Science Space (BUGSS). BUGSS Safety Manual. 2012, July 1.Google Scholar
  33. 33.
    iGEM: Synthetic Biology Based on Standard Parts. 2015. Accessed 1 Apr 2016.
  34. 34.
    White House Office of Science and Technology Policy. Doing diligence to assess the risks and benefits of life sciences gain-of-function research. 2014, October 17.Google Scholar
  35. 35.
    Gronvall GK. H5N1: a case study for dual-use research. Council on Foreign Relations Working Paper, 2013, July.Google Scholar
  36. 36.
    Ritterson R, Casagrande R. Basic scholarship in biosafety is critically needed to reduce risk of laboratory accidents. mSphere. 2017;2(2):e00010–7.CrossRefGoogle Scholar
  37. 37.
    Gryphon Scientific. Risk and benefit analysis of gain of function research. 2015.Google Scholar
  38. 38.
    Gronvall GK, Rozo M. Addressing the gap in international norms for biosafety. Trends Microbiol. 2015;23(12):743–4.CrossRefGoogle Scholar
  39. 39.
    Gronvall GK, Shearer M, Collins H. National biosafety systems. UPMC Center for Health Security; 2016, July.Google Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Department of Environmental Health and EngineeringJohns Hopkins Bloomberg School of Public HealthBaltimoreUSA
  2. 2.Johns Hopkins Center for Health SecurityBaltimoreUSA

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