As a veteran of the chemical research and development industry, I know first-hand that synthetic biology will revolutionise our work. This is not because it will just make our labour easier – it will do that too – but because it will enable us to make better chemicals, more sustainably and more smartly. No more trial and error.
Today, synthetic biology is poised to improve and reinvent how chemical manufacturers operate, making processes more efficient, sustainable, and astonishingly innovative.
Synthetic Biology: A Game Changer
At the heart of synthetic biology is the potential to engineer and re-engineer organisms to generate materials that are difficult, if not impossible, to produce by conventional chemical synthesis; more than just tinkering at the margins, it’s about rewriting the rule book. In the case of API manufacture, this means potentially producing new drugs at a speed and with a specificity that was previously unimaginable.
Pushing the Boundaries of Possibility
Think of microbes that synthesise sophisticated drugs or important chemicals from simple, renewable starting materials. Not only would this make production more efficient but, by reducing the amount of chemicals involved, it would also dramatically shrink the environmental impact of those processes. These are big ideas. They hint at a way to cut waste and dependence on non-renewable raw materials by factorial amounts.
The Ethical and Regulatory Landscape
For those of us who see the exciting but daunting new world of synthetic biology as an opportunity for chemical manufacturing, this ethical and regulatory landscape is a critical frontier that must be carefully traversed. The ability to engineer biological systems to accomplish complex chemical functions marks a new era of technological capacity, but also raises a host of ethical dilemmas and regulatory challenges.
But there are ethical considerations of much greater complexity, starting with biosafety. Artificially engineered organisms could, if not properly contained, interact with the ecosystem in unforeseen ways. The risk of accidental release or cross-contamination with natural organisms could prove ecological disaster in the short term, or the displacement of native species in the long run. Rigorous biosafety rules will have to be put in place to ensure that GMOs are safely contained and monitored.
Secondly, there is the question of biosecurity. While synthetic biology tools could be used to create beneficial organisms, they could also be used to create harmful biological agents. Given the dual-use functionality of its technologies, synthetic biology needs robust governance frameworks to ensure that its activities do not fall into the wrong hands, while ensuring that useful research can still be done. Detailed rules must be developed to regulate how biological data and materials are handled and shared in a secure manner.
Finally, the ethical use of synthetic biology requires that we address the moral responsibility involved in creating and altering life forms – that is, whether ethical questions of biological sanctity and integrity will be respected by a socially responsible science in how life is created and modified. Engaging in ethics consultations with a diverse group of stakeholders, including ethicists, the public, and industry, will help in developing an ethical consensus that guides how synthetic biology is moving forward.
Regulatory Challenges
Regulatory issues are equally daunting. The UK and other countries need to create legislation to ensure that synthetic biology is safe and fit for purpose. The fast pace of innovation means that there are no regulations currently in place to cover many of the new scenarios arising in API and chemical manufacture. Most existing GMO regulations deal with agricultural and food uses; extending these to cover novel products for use in industrial applications in chemical manufacture requires careful consideration and extension.
Furthermore, because synthetic biology research and application are inherently transnational, regulation will need to be coordinated internationally to manage the global risks and benefits of these technologies. For example, the Nagoya Protocol on Access and Benefit-Sharing – which addresses the fair usage of genetic resources – might be used as a model for future regulation of synthetic biological resources.
Moving Forward with Regulatory Frameworks
To do so, regulatory agencies need to be forward-looking, playing a role in the discussion about synthetic biology as it unfolds in the scientific community, rather than being called in only once new applications are developed. Regulatory agencies must have a robust enough framework to effectively address new information and technologies, and yet a flexible enough framework to be able to adapt to new knowledge and new methods.
One promising way to test out new regulations in this manner might be the adoption of a so-called regulatory sandbox for synthetic biology. A regulatory sandbox is a temporary environment in which new regulations can be tested by allowing controlled experimentation with real-world entities. For example, the UK’s Financial Conduct Authority has used a regulatory sandbox to test out new regulations in the fields of financial technology and crowdfunding. A synthetic biology sandbox might be a good way for regulators – in collaboration with researchers and companies in the field – to iteratively develop and refine synthetic biology regulations that are sensitive to the new challenges that synthetic biology could present, while at the same time being technically and scientifically sound and, importantly, both practicable and enforceable.
Overcoming Resistance from the Old Guard
As with any radical shift, there will be those who push back: powerful incumbent interests in the established approaches and margins might dismiss it as something quirky or threatening. But the reality is that this is more than a passing phase. It is nothing less than a radical innovation that the chemistry industry must embrace. The benefits of shifting to this new approach will be too great to resist. We should leave no stone unturned, and all the chemists need to be on board.
A Call to Embrace Innovation
That’s where contract chemical manufacturers could come in. They tend to be nimbler than big companies and more likely to respond to new technologies and processes. By adopting synthetic biology, they could lead from the front, demonstrating the commercial benefits of the new technologies.
Forging a Sustainable Future
This is not a conversation about ‘what can be done’ by contract chemical manufacturers but ‘what should be done’. We should move forward with a clear commitment to sustainability and ethical responsibility, and ensure that we use our advances to create a better world in the eyes of all, and not just a more technologically sophisticated one.
The future of chemical manufacturing, particularly the manufacturing of API and other complex chemicals, are clear: synthetic. By putting together the tools of synthetic biology, we can skip generations of environmental concerns and reach efficiencies that were sci-fi not so long ago. For those of us in industry, it will be our duty to lead the way, to educate, advocate and innovate – not only for the sake of progress, but for the sake of society and the environment.
