Emerging Policy Issues in Synthetic Biology

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Synthetic biology is at such an early stage of development that there is no uniform agreement as yet about what it actually is. To some, it represents a natural extension of genetic engineering, and therefore is “business as usual”. For others, it is a way to bring mass manufacturing out from the decades of biotechnology research. Currently the discipline is limited by the ability to synthesise DNA cost-effectively but this is a technical barrier that it is anticipated will be overcome. Synthetic biology raises a number of policy issues around R&D funding, company investment, PPP arrangements and innovative financing, infrastructure requirements, education and training, intellectual property (IP), regulation, and public engagement. In preparation for the continuing development and greater use of synthetic biology, some countries have started to prepare synthetic biology technical roadmaps and a global roadmap for the medium term would be an extremely useful policy tool. Technical roadmaps could both identify likely future policy requirements, and be a useful vehicle in public engagement.


Research infrastructure challenges for synthetic biology

While many of the fundamental laboratory techniques of biology and biotechnology are also applicable to synthetic biology, the major departure from the biological sciences tradition is in the development of technologies for the synthesis of large DNA sequences (of the gene and operon scale and above). Currently the cost of DNA synthesis lags a considerable way behind the spectacular advances in lowering the cost of DNA sequencing, although progress is being steadily made. In line with the aspirations to bring engineering standardisation to synthetic biology, there is a pressing need for new software developments, especially in design and manufacture. Chassis organisms, usually microorganisms engineered to be “minimal” life forms, are being developed as hosts for synthetic biology applications to reduce the noise and interference that is typical in biology. The bottleneck in synthetic biology is now shifting from DNA synthesis to dealing with the massive amounts of genetic and digital data being produced. If there is any role for co-ordinated international research infrastructure, it is to deal with this issue.


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