Perspective: The Rapidly Expanding Need for Biosecurity by Design.

Area of Science:

• Biotechnology and Synthetic Biology
• Biosecurity and Risk Management
• Bioethics and Global Norms

Background:

• Advancing biotechnologies, including synthetic biology, are transforming diverse sectors beyond medicine.
• The creation of novel biologicals necessitates robust safety and security measures for organisms and digital platforms.
• Traditional biosecurity, focused on pathogen access control, is insufficient for engineered biological entities.

Purpose of the Study:

• To reevaluate traditional biosecurity policies in light of new biodesign capabilities.
• To introduce and describe "Biosecurity by Design" approaches.
• To address the safety and security challenges in advancing bioeconomies.

Main Methods:

• Review and analysis of current biosecurity practices.
• Exploration of risk/benefit analysis and risk mitigation strategies for biodesign.
• Consideration of post-COVID opportunities and ethical global norms.

Main Results:

• Identification of limitations in traditional biosecurity for engineered organisms.
• Description of key features of "Biosecurity by Design" frameworks.
• Highlighting the need for integrated approaches to manage biodesign risks.

Conclusions:

• "Biosecurity by Design" is essential for safely advancing synthetic biology and bioeconomies.
• Updated policies must incorporate risk assessment and mitigation for engineered biological systems.
• Ethical considerations and global norms are crucial for responsible biodesign progression.