Are Existing Policies Regulating Recombinant DNA Technology Adapted for Synthetic Biology?


By Florence Chaverneff, PhD


Background on Synthetic Biology

Synthetic biology is gaining increasing interest as one of the most promising new technologies of the 21st century. Its revolutionary nature, wide-ranging applications across several scientific disciplines, and the fact that it may help solve some of the world’s most pressing issues, all contribute to the justified enthusiasm for the field. As the boundaries, prospects and even nature of synthetic biology still need to be clearly outlined, the definition advanced by a high-level expert group of the European Commission, encompasses it well: “Synthetic Biology is the engineering of biology: the synthesis of complex, biologically based (or inspired) systems which display functions that do not exist in nature. This engineering perspective may be applied at all levels of the hierarchy of biological structures-from individual molecules to whole cells, tissues and organisms.”


In the same manner that recombinant DNA technology revolutionized biology in the 1970s, synthetic biology is breaking new grounds. However, because it requires a greater need for DNA synthesis than recombinant DNA technology, synthetic biology brings life sciences closer to engineering. It aims to make biology easy to engineer. And that is the revolutionary part. Its multi-disciplinary nature at the nexus of biology, engineering, genetics, computational biosciences and chemistry implies that synthetic biology be practiced in a global and networked fashion, posing it as the ultimate collaborative venue for scientific research.


Applications of Synthetic Biology

The array of what synthetic biology allows to design and produce, from biomolecules, to cells, pathways, and ultimately, to living organisms, in by itself gives an idea of the power of the technology. Synthetic biology, with its new category of tools that allow advanced DNA synthesis, conceptualization of biologically complex systems, and standardization for mass production is more approachable to a less skilled workforce in a more efficient and manageable manner than what is currently practiced in biotechnology companies.


Applications of synthetic biology are wide-ranging, from global health (e.g. vaccine and antibody production, regenerative medicine, development of therapies for cancer, approaches for cell therapy) to generation of biofuels, to food production. And as the field is growing, technologies are bound to evolve, giving rise to an even wider array of applications. One of the most notable and highly publicized successes of synthetic biology was published in Nature Biotechnology in 2003. The article describes a novel way of producing the anti-malarial drug artemisinin, using the bacteria E. coli as a host, in which enzyme and metabolic pathway for artemisinin production were expressed. Artemisinin synthesized in this manner can be produced at much higher yield and much lower cost than by plant extraction. These considerations are of great importance for an anti-malarial drug, destined to large populations in low income countries.  Another powerful example of the promises held by synthetic biology lies in a study published last year in Science, reporting the assembly of a synthetic yeast chromosome, heavily edited from its natural counterpart, yet functional when expressed in its organism.


Crafting Policies for Synthetic Biology

Despite being over a decade old, synthetic biology is still in its infancy, its full potential has yet to be realized, and a regulatory framework indispensable to any new technology that can be applied to life sciences, will have to match the field’s evolution. Some policies for synthetic biology may be adapted from existing ones that were designed to regulate recombinant DNA technology and genetic engineering. However, it is critical that new regulations, tailored to synthetic biology, which is tantamount to engineering artificial life, be established. Considerable changes in regulations should be avoided, as they might result in holding up development of the fast-evolving synthetic biology.


Perhaps one of the most important policy aspects to consider for synthetic biology is linked to its sheer nature. Synthetic biology permits manufacturing of whole living organisms, which, if released in the environment, could greatly affect it by interacting with ecosystems. It is therefore imperative that preventive measures be taken and that ethical oversight be installed to avoid misuse of the technology. Another policy aspect particular to synthetic biology is related to its multi-disciplinary nature: all its practitioners, not just biologists, should be educated in biosafety. Additionally, policies should allow for training of scientist, researchers and other professionals to meet the demands of the field. Several top institutions in the US have already launched graduate programs in synthetic biology, but more educational programs are required.


Synthetic biology research and frameworks for funding are also vital to support evolution of the field by strengthening research and development capabilities, and supporting innovation. Synthetic biology should be practiced in academic institutions and private ventures alike.  In both instances, policies should be adapted so that results from research meet demands of modern economy, by taking measures to industrialize innovation in commercially successful ways through facilitation of technology transfer and intellectual property management.


Finally, because synthetic biology is heavily reliant on openness and sharing and holds great potential for becoming the poster child of international scientific cooperation, national policies formulated in the US and elsewhere could serve as template for transnational policies.