Beyond Containment: Designing Safe Genetically Engineered Microbes (GEMs) for Release

Advancements in bioengineering made way for the microbial chassis as a factory and delivery vehicle to address those challenges. The predictable outcome is a world where genetically engineered microbes (GEMs) become prevalent not only in modern medicine but also in household pantries, restaurants, and feedstocks. Currently, there are biocontainment avenues to limit the release of GEMs but with the introduction of GEMs specifically intended for release (e.g. probiotics, animal feed additives, soil additives, environmental remediation, etc.) there is little guidance for industry safety standards. We must be prepared to navigate, recognize, and mitigate many unknown unknowns that will inevitably arise with released GEMs. As innovation brings more intended release GEMs to the forefront, it is important that thought-leaders in the community work together to set cautious and thoughtful regulations around GEM safety. At ZBiotics, we aim to coalesce a proactive and scientifically motivated community that fosters transparency and product safety, and we are establishing some early standards with our GEMs that are already available for human consumption. We put forward conscientious engineering that utilizes genes and delivery mechanisms endogenous to the microbe or from other GRAS species to limit novel sites of homology and eliminate the danger of horizontal gene transfer to pathogenic bacteria. Our initiative highlights a method where safety is ingrained in the design. With our experience and vision for ubiquitous adoption of GEMs in daily life, we are engaging the scientific community in a dialog to further refine and adopt intrinsic biosafety measures.