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Biosecurity Is Synthetic Biology’s Most Crucial Ally

Updated: Oct 12, 2020



Synthetic biology has made it easier than ever to engineer organisms to serve our needs. But as the technology becomes widespread, concerns about its potential misuse arise. How can we ensure biosecurity without hindering the advance of synthetic biology?


Biosecurity consists in the prevention of and response to the release of potentially harmful organisms. Now that genetic engineering and synthetic biology are available to users outside established labs, biosecurity measures are becoming more important than ever

However, ensuring biosecurity without preventing technological advances is a gray area with many unresolved questions. Who can do bioengineering? Which applications are allowed and which are prohibited? How can regulations adapt to new technological developments?


Unclear regulations


The legal framework that governs synthetic biology and bioengineering in the European Union was established in the ‘90s as a response to genetically modified crops coming to the market. These technologies are mainly regulated by the European Medicines Agency (EMA) and the European Food Safety Authority (EFSA).


Different countries have different rules on what is permitted, but most of these regulations address cases where a gene from one organism is transferred to another. This approach is problematic when applied to new synthetic biology applications such as precision gene editing or cell-free synthetic biology. 


Andreas Meyer, CEO of the Basel-based biopharma company FGen, dismisses any major concerns about whether the lack of clear regulation around synthetic biology may discourage companies from adopting new technologies. “[We] just need updated regulatory guidelines regarding modern technologies such as CRISPR.”


The regulatory authorities in the EU, in particular the European Food Safety Authority, which deals with the approval of genetically modified organisms, are still trying to figure out the differences between genetic engineering and synthetic biology,” said Victor de Lorenzo, group leader at the CNB-CSIC research institute in Madrid. 


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