Biosafety and Biosecurity: Core Challenges for SynBio Founders
Takeaway: For synbio founders, biosafety (protecting people from germs) and biosecurity (protecting germs from people) are not just compliance issues but intertwined ethical obligations that require a holistic approach to building a culture of responsibility.
In the world of synthetic biology, the terms "biosafety" and "biosecurity" are often used interchangeably, but they represent two distinct, critical, and deeply intertwined concepts. For a founder, mastering both is essential. They are the twin pillars that support the responsible practice of this powerful technology.
Biosafety is about protecting people and the environment from accidental exposure to biological agents. It asks the question: "How do we keep our science safely contained in the lab?"
Biosecurity is about protecting biological agents from malicious use. It asks the question: "How do we prevent bad actors from stealing or misusing our science?"
While one is focused on accidental release and the other on intentional misuse, they share a common foundation: a deep commitment to responsible stewardship, rigorous risk assessment, and a culture of vigilance.
The Core Challenges of Biosafety
As we've discussed, biosafety is managed through a framework of risk assessment and contained use (Biosafety Levels 1-4). For a startup, the primary challenges are:
Scaling Safely: The safety protocols that work for a small-scale experiment may be inadequate for a large-scale fermentation run. Your biosafety procedures must evolve as your company's operations grow in scale and complexity.
Training and Culture: The best safety cabinet in the world is useless if the person using it hasn't been properly trained. Biosafety is fundamentally a human endeavor. It requires continuous training and the cultivation of a "safety-first" culture where every employee feels empowered to identify and report risks.
The Unknowns: Synthetic biology often involves creating organisms with novel functions. While you can make predictions based on the genetic parts you use, you must be prepared for the possibility that your engineered organism may have unexpected properties. This requires a humble and cautious approach, starting all new projects at an appropriate level of containment until they are well-characterized.
The Core Challenges of Biosecurity
Biosecurity addresses the "dual-use" dilemma—the fact that the same technology that can be used for immense good could also be used for harm. The core challenges include:
Insider Threat: Protecting your valuable strains, plasmids, and data from being stolen or misused by a disgruntled employee or a foreign agent. This requires robust physical security (access controls, surveillance) and cybersecurity measures.
Information Hazards: How do you publish your groundbreaking research in a way that enables scientific progress without providing a detailed recipe for a potential bioweapon? This is a complex ethical question that the entire field continues to grapple with.
Screening and Verification: As discussed previously, this involves measures like screening DNA synthesis orders and "knowing your customer" to ensure that your platform and services are not being used for nefarious purposes.
For a synbio founder, biosafety and biosecurity are not boxes to be checked. They are an ongoing, dynamic process of risk management and ethical deliberation. They require you to think not only as a scientist and an entrepreneur, but also as a guardian of a technology with the power to shape our world for better or for worse. Building a company that is both innovative and responsible is the ultimate challenge and the greatest opportunity.
Disclaimer: This post is for general informational purposes only and does not constitute legal, tax, or financial advice. Reading or relying on this content does not create an attorney–client relationship. Every startup’s situation is unique, and you should consult qualified legal or tax professionals before making decisions that may affect your business.