Synthetic biology: crash course

Did you know you can now buy a genetic engineering kit and design your own life form?

The newly appointed Head of Innovation at Lloyd’s, Trevor Maynard, has called for the insurance industry to “ramp up” its investment in innovative new products and technologies. Speaking at the Old Library in Lloyd's earlier this year, out of the three emerging risks he highlighted - autonomous vehicles, food system shock and synthetic biology – synthetic biology is probably the most unfamiliar to many insurance professionals.

That will begin to change as the industry develops: in March 2016 synthetic biology was reported to have yielded the first man-made species, created by American entrepreneur J. Craig Venter. Risk professionals will need to catch up quickly.

What is synthetic biology?

Biological engineering has traditionally taken a top down approach, by tweaking existing organisms and viruses. Synthetic biology, in contrast, involves the building of biological systems from basic, often synthetic, building blocks. This has recently become possible due to advances in genetics, chemistry and computer science, which enable scientists (and now entrepreneurs) to “print” nucleic acids (DNA or RNA) and other modular cellular components, to design and assemble into biological systems and even living organisms.

The technique has similarities to engineering and computer programming, and online databases of tens of thousands of standardised parts and system designs have emerged, for example MIT’s Registry of Standard Biological Parts, which is based on an open sharing concept: the Registry website uses Wiki technology.

An emerging industry

The technology is being picked up by established biotechnology companies as well as start-ups. A December 2016 report by Cambridge Consultants for the UK Synthetic Biology Leadership Council identified 275 synthetic biology start-up companies (less than 10 years old) in existence worldwide. Most are in the USA, followed by the UK with 37 concentrated in London, Cork and Cambridge.

The report identifies “synthetic biology tools” as the most popular focus of all synthetic biology start-ups, which is the development of standardized, modular parts to use as building blocks with which to design whole systems. Other applications include biomedical and industrial chemical applications (bacteria, for example, can be designed to synthesize chemicals), followed by consumer, software, agriculture and environmental applications. A significant proportion of start-ups globally are close to market readiness.

In the US, synthetic biology is already accessible to the average consumer. Ward’s Science, a manufacturer of classroom science supplies, offers a synthetic biology kit for US$140 which children use to create cells which emit a ripe-banana smell, whilst another kit allows the creation of different coloured cells. In the UK, a DNA printer now costs under £700.

Regulatory considerations

The start-up companies and the sellers and wholesalers of “kits” will face the same daunting array of health, environment and transport rules applicable to large life sciences firms.

Regulators are wondering whether existing rules governing “genetically modified organisms” (GMOs) are broad enough to cover new organisms and/or parts manufactured from non-living material, without any existing organism being altered. The Genetically Modified Organisms (Contained Use) Regulations 2000 was replaced by a new set of 2014 Regulations of the same name, which the Health and Safety Executive has said was intended to account for, amongst other things, synthetic biology. The Executive’s guidance says that GMO shall be construed to include an organism made synthetically, though it distinguishes between “GM” and “synthetic” organisms elsewhere in the guidance.

Semantic stretches aside, this does probably cover off the lacuna in the legislation to which the guidance applies, although further regulatory changes may be needed in other areas.

Comment

A July 2009 report by Lloyd’s on synthetic biology appropriately describes designers of synthetic biology tools and systems as engineers: a professional class who, like any other professional, will endeavour to carry out error-free work but who must manage the potential social, ecological and public safety implications.

Insurers of both established and new biotechnology companies need to consider what risks might arise from the retail trade in synthetic biology kits, the biological systems they create and their (intentional or unintentional) by-products.

The industry, however, will also be selling to the public to do their own “engineering”. Health and safety, product liability and third party liability risks will all need to be assessed.

As with the computer sciences, hacking could become a danger, and as with IT this may found a new breed of professionals who work to counter such risks. Artificial organisms are arguably far more complex, and susceptible to mutation from environmental stress, possibly leading to evolution. Whilst biology is undergoing a revolution in understanding and technology, there is still so much which is unknown.

Life sciences insurers and brokers will need to get up to speed with the risk profile of this exciting new industry. However, the unique potential for the commoditization of synthetic biology means that risks will fall more widely, potentially impacting upon the directors, advisors or businesses who will soon be selling something which is, in the US, already being marketed as a child’s toy.

Read other items in the London Market Brief - January 2018