Perspective: The Rapidly Expanding Need for Biosecurity by Design.

Advancing biotechnologies are revolutionizing not only health and medicine, but also many different sectors such as agriculture, energy, chemistry, and textiles. As synthetic biology is leveraged as a programmable platform for the creation and biodesign of high-value biological medicines, foods, and commodities, the world is facing new territory in terms of ensuring the safety and security of both novel and engineered biological organisms, as well as the biological and digital platforms in which they are designed. Biosecurity practices and policies have traditionally revolved around preventing the misuse of biological pathogens, primarily through controlling access to pathogens. The advent of biodesign capabilities, such as gene editors, gene synthesis capabilities, and genetic engineering, requires a reevaluation of traditional biosecurity policies to mitigate risks associated with such engineering of biological entities. Here, features of "Biosecurity by Design" approaches are described, including the application of risk/benefit analysis and risk mitigation, post-COVID opportunities, and ethical global norms in the progression of biodesign and growing bioeconomies.