Synthetic biology offers great promise for curing diseases and creating new fuels and products. Indeed the first drugs and foods created using synbio technology are now coming to market. But this new industry is not regulated properly. Here’s the story.
Synthetic biology (or synbio for short) has been described as genetic engineering on steroids.
Ordinary genetic engineers try to improve natural organisms by moving genes from one organism into another, to create (for example) a tomato that does not bruise easily, while synthetic biologists generate new DNA sequences in order to create (synthetise) new life forms.
To many people this sounds a bit scary. But proponents of synbio believe that the invention of new forms of life will make it possible for mankind to benefit from all kinds of new products and services.
Synbio drug for malaria
Indeed synbio companies have already performed a few minor miracles. For example, Amyris, a company based in California, has used synbio technology to create a new anti-malarial drug.
Malaria is a preventable, curable disease that claims the lives of more than half a million people a year, many of them children under five years of age in Africa. The disease has evolved over the years.
It is now resistant to many of drugs that were once effective in treating it. In fact there is only one anti-malarial treatment that still works properly—Artemisinic acid.
Artemisinic acid comes from the wormwood tree, a tropical plant. Amyris figured out how the tree generates the acid and then programmed a strain of yeast to do the same thing.
In 2013, Sanofi-Aventis began using Amyris technology to manufacture artemisinic-based anti-malarial drugs. The only problem is that malaria is developing resistance to these drugs, so both the Amyris synbio version and the natural version will eventually be useless.
Nevertheless, faith and research in synbio is ongoing at a rapidly increasing pace, with many new products being mooted or attempted.
Craig Venter is an American entrepreneurial biochemist and geneticist, one of the first scientists to sequence the human genome and the first to introduce a synthetic genome into a cell. In 2011, he announced that he is synthesising an algae that will use sunlight to release the energy in carbon dioxide.
Should he succeed, carbon dioxide could become a limitless source of energy. Unfortunately Venter has not yet worked out how to grow his synbio algae cheaply enough to make it competitive with fossil fuels.
Other synthetic biologists are equally ambitious.
How’s about medicines tailored to your body’s needs, glowing trees that would replace streetlights, or being able to grow buildings instead of having to construct them?
But don’t expect major breakthroughs like these anytime soon—except in the realm of foodstuffs.
Natural vanilla is obtained from the seed pods of the vanilla orchid. It is a complex blend of compounds, within which the most important component is vanillin.
Vanillin is mainly used as a flavour-enhancer in confectionery and dairy products. It is also used in perfumes and cleaning products, and to mask unpleasant tastes in medicines and livestock fodder.
Because of the cost and scarcity of the natural product, synthetic vanillin, derived from petroleum, is widely used for products such as ice cream. Indeed, synthetic vanillin supplies virtually the whole of the market for vanilla.
Evolva, a Swiss company, has invented a yeast-based fermentation method to produce vanillin and other components found in the vanilla seed pods, as an alternative to existing synthetic vanillin products.
The company claims that its synbio product has a superior taste and is cheaper to produce than convention petroleum-based synthetic vanillin.
The first revenues are expected to flow in the second half of 2014, so you can expect synbio vanilla in your ice cream very soon.
More synbio products
Evolva is also about to release a synbio version of resveratrol, a natural compound with anti-oxidant properties found in grapes and cocoa beans.
After that, its next product is expected to be a synbio version of stevia.
Stevia is a substitute for sugar made from the leaves of the stevia plant. Its taste comes on slower and lasts long than that of sugar.
It can also be up to 300 times sweeter than sugar, yet it has a negligible effect on blood glucose, making it very attractive for diabetics and people on carbohydrate-controlled diets.
The problem with natural stevia is that sometimes it leaves a bitter aftertaste. A synbio version with a better taste that could replace synthetic chemicals in diet sodas would be welcomed by the beverages industry.
After stevia, Evolva hopes to create more lab-grown analogues, including musk and truffle. Its ambitions even extend to breast milk.
The possibilities of synbio and fake DNA are exciting. What could go wrong with vanillin, resveratrol or stevia brewed by yeast that has had its DNA manipulated?
Nobody knows and probably won’t know until something goes dramatically wrong.
The synbio regulatory void
As synthetic biology is a relatively new field, there are no rules or regulations in the USA or in the EU purposely designed to control synbio products per se.
However, current regulations governing more traditional biological research also apply to synbio and its products.
In the USA, four agencies govern research on and the commercial production and use of genetically modified microbes, plants, and food and drugs—the NHI (National Institutes of Health), the EPA (Environmental Protection Agency), USDA (US Department of Agriculture) and the FDA (Food and Drug Administration).
Thus there is no one agency with overall control over this new industry in the USA where much of the research is taking place.
In addition, many of the controls are very weak. The EPA, for example, requires companies to file a report on novel microbes but doesn’t always make testing compulsory.
In the European Union (EU), regulation relies on the implementation of directives issued centrally by the EU being incorporated into the laws of individual member states. Thus it can take years for new regulations to become legally enforceable throughout the Union.
Even then, the strength of the actual rules at state level and the degree to which they are enforced will vary from state to state.
The market for synbio is expected to reach US$13.4 billion by 2019. Yet synbio falls into a regulatory void that can allow products to go from laboratory to supermarket with little or no oversight, simply because they are versions of already-existing compounds.
In America, for example, Evolva expects its vanillin and resveratrol to sail through the FDA’s approval process because they are versions of already-existing compounds that are recognized as safe.
So it seems likely that these synbio products will end up on American food-shelves without any special labelling.
The promise of synbio
Nevertheless, synthetic biology holds great promise for curing diseases, creating fuels, developing products and solving countless other problems faced by humankind. It may even save mankind, as some of its proponents seem to believe.
Unfortunately, the risk of improper use of synbio technology, whether accidental or malicious, creates a need for regulation and supervision by a single agency.
But how effectively can synbio, which is characterised by rapid change, exceptional complexity and substantial uncertainty, be regulated and controlled? We’ll only find out sometime in the future.
In the meantime, no fake DNA for me thanks. Though synbio stevia sounds like it was custom-made for diabetics with a sweet tooth, I’ll avoid synbio products by sticking to the plant-focused natural diet I am using to successfully control my blood glucose and beat my diabetes.