In this dissertation, the author explores the application of software engineering principles to synthetic biology and addresses emerging regulatory concerns.
Using an interdisciplinary approach, this dissertation lays foundations for verifying, validating, and certifying safety and security of synthetic biology applications through traditional software engineering concepts about safety, security, and reliability of systems. These techniques can help stakeholders navigate a confusing regulatory process. This study creates domain-specific patterns to help synthetic biologists develop assurance cases using evidence and arguments to validate safety and security of designs; applies software product lines and feature models to the modular DNA parts of synthetic biology commonly known as BioBricks, making it easier to find safety features during design; establishes a technique for analyzing DNA sequence motifs to help characterize proteins as toxins or non-toxins; performs a legal investigation regarding what makes regulating synthetic biology challenging; and implements a repeatable workflow for leveraging safety and security artifacts to develop assurance cases for synthetic biology systems. Synthetic biology is an interdisciplinary engineering domain, and interdisciplinary problems require interdisciplinary solutions. Recent progress indicates synthetic biology will produce transformative breakthroughs. Although synthetic biology promises great benefits, many stakeholders have expressed concerns over safety and security risks. As with any emerging technology, there is the risk of malicious use known as the dual-use problem. The technology is becoming democratized and de-skilled, and people in do-it-yourself communities can tinker with genetic code.