Building the Bioeconomy Requires Addressing Biosecurity Globally

The following article is an opinion piece written by Sophie Peresson. The views and opinions expressed in this article are those of the author and do not necessarily reflect the official position of Technology Networks.

Given the growing importance of biotechnology and biomanufacturing, it is surprising that there is currently very little by way of consensus-based guidance for biosecurity. In fact, there is often confusion with the related term biosafety which focuses on safety measures aimed at minimizing the risks of exposure to biohazards in the lab. What biosecurity focuses on is preventing the misuse of technology and biological materials that have the potential for harm. It is an important distinction because labs cannot simply apply biosafety measures to biosecurity questions. We need a new set of best practices to ensure that scientists use technologies safely and responsibly.

The United States was one of the first countries to offer some guidance around biosecurity. These were issued by the Department of Health and Human Services (HHS) in 2010 — the HHS is in the process of updating its guidance. But few other countries have followed suit. There are also patches of activity from groups of stakeholders. For example, the Organisation for Economic Co-operation and Development is hosting a global forum that may also include a focus on synthetic biology and biosecurity. In addition, there is promising action from the Nuclear Threat Initiative and the Engineering Biology Research consortium who have prioritized biosecurity and are critical partners in efforts to move the needle.

But what the community really needs is greater visibility globally on biosecurity issues and strategic leadership from multiple stakeholders to drive the conversation around standards and best practices.

Globally, biotechnology and biomanufacturing companies are taking center stage. Around the world, scientists are developing novel technologies that are enabling important breakthroughs.  In the US alone, the bioeconomy is valued at nearly $1 trillion and growing quickly, powered by innovative technologies like gene editing and DNA writing, bolstered by the recent executive order from the Biden administration regarding investment in the space.

While the potential benefits of synthetic biology are many and profound, in the wrong hands, these tools can cause irreparable harm. Developing guidelines that govern responsible innovation coupled with technological advancements for monitoring how life science systems and instruments are used will help us anticipate and mitigate many of those risks.

 Why guidance matters

Improvements in things like automation and miniaturization technologies have made it possible to develop smaller, portable versions of once large instruments. For example, many laboratories have systems for designing and printing their own DNA sequences quickly that can fit on a table and use less power and consumables. Designing and printing DNA in-house can be more cost-effective and addresses potential supply chain problems from DNA manufacturers. During the COVID-19 pandemic, scientists with access to in-house DNA printing systems could continue printing their own DNA allowing them to keep working on vaccines for the virus. These instruments can also be useful in field laboratories during outbreaks where space and resources are often limited.

Democratizing access to different technologies has helped advance science but there are risks. Staying with the synthetic biology example, greater access to instruments and consumables for producing DNA means more opportunities for misuse and accidents. Creating a set of updated and consensus-based best practices would minimize the risks of unauthorized individuals or people with malicious intent using technology for nefarious purposes such as synthesizing toxins and other harmful agents. Sample guidelines might for example require scientists to submit formal requests and implement specific safeguards prior to performing certain types of experiments or creating products that have the potential for harm.

The technological side of biosecurity guidance

The best practices will also need to cover instrument development as well. There is some activity from the private sector such as a 2017 protocol from the International Gene Synthesis Consortium, which sets out some best practices for assessing things like the screening depth for sequences and provides a forum for exchanging information and sharing updates. Other potential biosecurity measures for companies could include computational solutions for monitoring and communicating with them on how they are using their systems, as well as mechanisms for shutting down systems remotely in case of misuse.

Implementing these practices will not be trivial. There are significant financial and time costs associated with conducting additional screening that can delay order fulfillment, and ultimately slow the pace of research and development. Any proposed monitoring systems will need to scale to support growing customer demand. There are also questions about how compliance with the best practices will be enforced across the board. Customers may be tempted to take their business to companies that opt out of complying with the best practices to save time and money.

Consensus is possible

The synthetic biology community is behind where it needs to be in terms of effective leadership for biotechnology and biomanufacturing. There are patches of activity around regulation and guidance, but it is far from sufficient. We need broad-ranging best practices that support responsible innovation and technology use.

Developing a shared understanding of and shared definitions about biosecurity and what it entails is the first step. It will require input from multiple stakeholders including representation from government agencies in addition to the private sector. Without their contributions, coming up with clear guidelines that are then deployed and adopted by the greater global science community will be challenging.

It is also critical to find a balance between the need to regulate and the need to foster innovation, given that synthetic biology will be critical to tackle future pandemics and other major challenges. Too much regulation may have the unintended side effect of stifling innovation. The synthetic biology market is very competitive and too much regulation can slow research and development efforts or give companies that choose not to implement the best practices an unfair advantage. Government agencies can help by, for example, offering incentives for meeting or exceeding biosecurity guidance.

If countries across the globe are serious about investing in building the bioeconomy, then concerns about biosecurity must be addressed. These cannot be solved by using siloed approaches or relying on the expertise of a handful of people. It will require input from government agencies, subject matter experts and industry representatives, as well as a plan for revisiting and updating proposed guidelines as technologies evolve. Creating space for dialogue between these stakeholders is a critical first step in making progress.

About the author:

Sophie Peresson serves as head of public affairs at DNA Script.