Setting standards for synthetic biology
Standards are traditionally claimed to be one of the pillars of modern engineering and as such they are also vindicated as one of the core tenets of contemporary synthetic biology – which is basically looking at biological systems through the eyes of an engineer. Standardization of physical assembly of DNA-encoded genetic parts was one of the first issues that the early pioneers of synthetic biology at MIT pointed to as being critical for the development of the field. This is still today one of the principles of the iGEM student competition and its associated repository of biological parts. But soon after the issue was raised more than a decade ago, an avalanche of criticism followed, because regardless of how one standardizes physical composition, the result is not a predictable functional outcome, as biological activities delivered by given DNA segments are context-dependent in practically all cases. This raised the question: should we simply give up robust design of biological systems with new-to-nature properties?
A lot has happened since those days. There has been an increased effort to develop orthogonal devices and even complete systems that are intended to work in a fashion minimally dependent and even autonomous of the biological host. These involve not only a suite of genetic patches and expression systems based on phage polymerases, but also recoding and/or expansion of the genetic code. Also, physical assembly of DNA pieces is no longer an issue, due to the ease of chemical synthesis and the onset of many procedures for composing genetic constructs that do not use restriction enzymes.
More importantly, the debate on standards has moved beyond technicalities on DNA composition, now focusing on what else can and should be standardized. For example, how do we measure biological activities? And, along the way, the sector has added benchmarks for synbio practices, including risk assessment methods.
At the same time, the growing awareness that synbio can ultimately become a transformative technology has prompted a (mostly implicit) footrace for who will succeed in establishing the rules and standards that will shape the field of synbio for the future.
There is a general sentiment that the level of knowledge right now is not sufficient to address standards in biological design with the same rigour as electric or civil engineering does. There have indeed been partial advances in metrology and proposition of operating systems in living organisms, but most standards proposed thus far have not made it beyond very limited communities of users. There is still a considerable wander in the wilderness that the synbio community has to go through before reaching the promised land of full-fledged standardized biology!
In the meantime there is a remarkable (and worrisome) difference in the interest of the US and EU agencies on the issue at stake. The American National Institute of Standards and Technology (NIST), belonging to the United States Department of Commerce, has been very proactive in bringing together a great number of US synthetic biologists from academia and industry by means of specialized workshops and follow up networking.
Their agenda includes both getting things done through a solid research program and, of course, establishing early US leadership for whatever development may come later. In contrast, no EU level-related agency or stakeholder on standards has expressed thus far the slightest interest in becoming involved in the synbio standardization process. Every proposition to develop a European Institute of Biological Standards that could team up and compare with US initiatives has been ignored, ridiculed or turned down (with the stand-alone 4-year EC research project ST-FLOW being the only exception).
This means that when the field will be ripe to deliver, Europe will be reactionary, losing an opportunity to partner with our US peers. But do not blame only Brussels bureaucracy. The EU-based synbio community is both mesmerized by the awesome (and quick!) progress made in the US, and engrossed in the difficulties of scientific bottlenecks. By focusing only on scientific bottlenecks we may gain more knowledge, but will altogether lose any chance of being global players in the bioeconomy that will be brought about by synbio.
We Europeans pride ourselves on producing the best local gourmet food, the key ingredients needed for a chef’s inspiration. Yet we often disdain the multi-billion business of franchised, standardized food. Setting standards is not only a decision between quality and quantity, but it is also the basis of a successful bioeconomy and a flourishing society. Science needs freedom to operate, but as European society longs for a knowledge-based bioeconomy, we cannot ignore the risks of simply signing up for heteronomous standards developed by others!
 According to the International Standards Organisation (http://www.iso.org) ISO a standard “provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.“