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August 24, 2015

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Ask the professionals: Synthetic biology

Genetic engineering and DNA manipulation as the biotechnology science of genetically modified foods or living organisms with anThis month Craig Poland from the Institute of Occupational Medicine (IOM) highlights the emerging field of synthetic biology, its potential uses for society and the risks it may pose.

Craig Poland is senior toxicologist within the analytical sciences division at the IOM and leads on providing research and consultancy services in toxicology and hazard assessment.

What is synthetic biology?
Synthetic biology (SynBio) is a new scientific discipline that links biotechnology and genetics with the application of engineering approaches to the creation of biological systems. Fundamentally, it can be seen as the design and engineering of biological ‘parts’ which can be combined to form new and novel structures and systems such as artificial cells.

The EU Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) defines it as “the application of science, technology and engineering to facilitate and accelerate the design, manufacture and/or modification of genetic materials in living organisms.”[1]

This definition embodies the idea that synthetic biology and genetic modification are fundamentally the same in terms of the technology although the aims and specific outcomes may differ between the two fields.[2]

The increase in interest is due to the enormous technological advances in genetics and molecular biology, including the sequencing of organisms such as E. Coli and other key model organisms in biological engineering research. These technological advances have led to a wider availability and affordability in biological components, reagents and equipment.

Advances also include the availability of ‘off the shelf’ biological parts, which are sections of DNA encoding specific functions that can be combined to form a ‘device’ to perform a function (e.g. produce a protein), and which can be inserted into a similar off the shelf cell chassis to facilitate the device’s function.[3]

Growing interest in SynBio has been demonstrated in the funding activities of various UK Research Councils, including the establishment of various world-class research centres. SynBio has also reached out to a new generation of technologists and hobbyists in a way not often seen in biological sciences, as embodied by the International Genetically Engineered Machine (iGEM) competition; a worldwide synthetic biology competition in which high-school, undergraduates and masters’ students compete to design and build genetically engineered systems using a range of standard biological parts supplied as part of the competition.

What are the benefits of Synthetic biology?
SynBio is an enormously flexible technology and the areas in which it can be applied and the societal benefits it may bring are highly diverse. An example is its application in the production of compounds such as proteins, pharmaceuticals, fuels, chemicals and materials through the development of microbial cell ‘factories’. This is nothing new: E. Coli has been used for decades in the production of insulin but SynBio allows the development of a more diverse range of products, larger-scale production with higher yields making such activities more commercially viable.

Other applications could include the medical sector through the development of biosensors, smart therapeutics to detect and treat disease and also environmental applications such as drought resistant crops. One example is bioremediation whereby organisms are engineered to mineralise contaminating compounds found in the environment.

What are the associated risks?
The development of a synthetic organism, modified to perform a new or altered functions, brings with it the potential for adverse effects, be they unintentional (accidental) or even intentional (e.g. bio-terrorism). However, at this stage, the potential for harm is largely speculative but there is concern that there is insufficient knowledge about the potential behaviour/ risks of synthetic organisms and also that a ‘bio-hacker’ culture, could result in the unintentional development of dangerous organisms.[4]

A risk management flow chart handwritten with chalk on a blackboard.One area of concern is the unintended impact of engineering enhanced abilities, such as an organism’s ability to withstand normally toxic conditions. This may have clear benefits in terms of bioremediation but may also create an organism that can thrive on a wider variety of nutrients than its native counterpart5 and therefore dominate. Equally, modification resulting in resistance to one harmful substance may cause the unintended resistance to other, more useful and important substances such as antibiotics.

To date no incidents have happened and speculation, where it is based on plausible scenarios, is useful because it allows careful consideration of the risks and ways to mitigate them, for instance, thorough controls, governance structures or even improving the industry and public’s knowledge of the potential risks.

What safeguards are available?
As with any technology, there are safeguards that can be used to limit the release and/or prevent exposure of workers, consumers or the environment, for example through the use of closed processes.

However these processes, while suitable for certain uses of synthetic organisms (such as the production of pharmaceuticals), may not be suitable for all applications. An example of this would be the application of synthetic organisms to soils for bioremediation or use in agriculture.[5] In these applications, it is impossible to control the spread or interactions of such organism with natural biota.

The potential for dissemination of synthetic organisms to the broader environment through both the unintended (e.g. accidents) and intended (e.g. use as an oral therapeutic) uses has increased with the development of SynBio and its potential applications. Therefore, other safeguards are needed to mitigate against unintended consequences and one that is unique to SynBio is the application of biological (genetic) safeguards which can be employed to control the proliferation and interactions of synthetic organisms (see Moe-Behrens, Davis[5] for an introduction to such safeguards).

How effective are these safeguards?
These safeguard mechanisms embody the ‘safe-by-design’ idea; safeguards literally have to be designed into a developed synthetic organism otherwise they do not occur and so equally, can be left out of a design. A key issue with genetic safeguards is, as with all genetic material, they can be subject to mutation resulting in deletion of the genetic switch or perhaps conferring immunity to the organism thereby negating the safeguard.

Other safeguards include the use of well conducted risk assessments, applied before the progression of an activity. It should be acknowledged that such assessments are not simply a tick-box exercise, but instead a powerful tool in both safe and responsible use of an important technology.

A recent analysis of the evolving safety policies within iGEM competition[6] showed the importance of having clear knowledge of the work being undertaken, the safety implications and the rules/regulations to avoid mistakes in reporting and potentially more serious consequences.

Rather than causing alarm, raising issues at such an early stage in the technological development of SynBio and the willingness of the SynBio community to discuss, question and evolve safety practices is reassuring. It is without these activities or where safety is not considered as a key part in the responsible development of new technology when alarm is needed.

Is synthetic biology regulated?
SynBio has not emerged in a regulatory vacuum and as acknowledged in the SCENIHR definition of SynBio, synthetic biology and genetic modification are fundamentally the same. This means that the existing regulations and existing guidelines for biologically and genetically modified materials also apply to SynBio.[2]

However, an important question to ask is: “are the existing regulations and methodologies suitable for assessing the potential risks”? SCENIHR has sought to answer this question. It found that existing risk assessment methodologies that addressed genetically modified organism and chemicals are applicable yet certain properties of SynBio, for example, the combination of genetic parts and the new properties which may occur as a result will require new methodological approaches.[7] Recommended changes included a greater understanding of the function of biological parts and in particular new computational tools to help predict the properties and behaviours of SynBio organisms.

How do can we balance risks?
In considering the openness and accessibility of SynBio and the drive for do-it-yourself biology or ‘bio-hacking’ culture, concern has been raised over the potential for accidents or indeed intentional development and release (or threat) of an injurious agent (e.g. bio-terrorism). A significant barrier to the emergence of ‘homemade’ approaches to biological research is the need for expensive specialist equipment and access to reagents, not found outside professional research facilities. Such facilities in turn are likely to have the knowledge, procedures and risk assessments in place to assess the relative risk issues to deal with materials safely. With the increasing simplification of techniques and equipment, wider availability of previously specialised parts (e.g. cells chassis, genetic material), such barriers may be reduced.

Regarding the potential consequence of greater SynBio research outside of the traditional research environment, one could draw an analogy with computing and how knowledge of the basics (e.g. coding), access to equipment (a computer) coupled with imagination and drive can lead to many great advances.

However, through malevolent intent, it also led to the development of computing viruses such as malware, which can cause significant harm. Instruction on how to develop computer viruses is widely available on the internet and so it should not be assumed that the same would not be applicable to SynBio despite the wider ethos among the community to do no harm and be a force for good.

Even so, while there are negative aspects that have been associated with the development of computers and programming, the overwhelming impact is one of progress and development with an incalculable benefit to society. It is impossible to imagine a world in which the advancement of computing had been curtailed through fear of its application for negative purposes. The same could be said for SynBio in that its potential for good is enormous but, as for any technology, it does hold the potential for harm and an approach to the development of SynBio based on speculation and fear will not benefit anyone. Instead the risks and real (not hyped) benefits must be understood, discussed in an open and frank manner based on the scientific evidence and, ultimately, mitigated.

Craig is senior toxicologist in the analytical sciences division at the Institute of Occupational Medicine


  1. SCENIHR, Opinion on Synthetic Biology I: Definition 2014, Scientific Committee on Emerging and Newly Identified Health Risks: Luxembourg.
  2. Breitling, R., E. Takano, and T.S. Gardner, Judging Synthetic Biology Risks. Science, 2015. 347(6218): p. 107.
  3. Baldwin, G., et al., Synthetic Biology: A Primer. 2012: Imperial College Press London.
  4. Tait, J., Governing Synthetic Biology, in Appropriate Governance of the Life Sciences. 2012, ESRC Centre for Social and Economic Research on Innovation in Genomics Edinburgh.
  5. Moe-Behrens, G.H., R. Davis, and K.A. Haynes, Preparing Synthetic Biology For the World. Front Microbiol, 2013. 4: p. 5.
  6. McNamara, J., et al., Designing Safety Policies to Meet Evolving Needs: iGEM as a testbed for proactive and adaptive risk management. ACS Synth Biol, 2014. 3(12): p. 983-5.
  7. SCENIHR, Preliminary Opinion on Synthetic Biology II: Risk Assessment Methodolgies and Safety Aspects. 2014, Scientific Committee on Emerging and Newly Identified Health Risks: Luxembourg.

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