Strategies for designing, testing and demonstrating safety : what synthetic biology can learn from retrospective cases

Abstract

Synthetic biology is an emerging technology field within the realm of genetic engineering, differing from traditional genetic engineering in that it focuses on the modularization of genetic parts and the creation of de novo organisms. Significant concerns over safety have been expressed. This research explores traditional engineering and biotechnology practices for overarching principles of design, testing and demonstration that address safety concerns. The information is used to assess the current state of design, testing and demonstration in current synthetic biology projects addressing safety. Component and system design literature provide an engineering backbone of safety systems however, biological attributes such as mutation, growth, and multiplication create safety gaps, where biological engineering practices are needed. These principles are organized into categories of design and testing, and testing and demonstration to gain greater insight on where gaps in the literature might lie. Retrospective cases of traditional engineering and current cases of biotechnologies provide external validation and further illustrate which practices address which design, testing and demonstration needs. While most of the traditional engineering cases addressed safety through design and testing, when they were faced with questions of safety, they presented specific efforts to gain public confidence. The pro-biotics case was different in that the safety concerns came from the scientific community since history is being used as the convincing demonstration of safety. The three synthetic biology research projects cross the divide between traditional engineering and biotechnologies, but theses efforts are firmly in the area of design and testing. These efforts begin to show the tradeoff between implementing safety and faster technical results. Strategies for further research are explored.