Preparing for the future of precision medicine: synthetic cell drug regulation

Abstract

Synthetic cells are a novel class of cell-like bioreactors, offering the potential for unique advancements in synthetic biology and biomedicine. To realize the potential of those technologies, synthetic cell based drugs need to go through drug approval pipeline. Here we discuss several regulatory challenges, both unique to synthetic cells, as well as challenges typical for any new biomedical technology. Overcoming those difficulties could bring transformative therapies to the market, and will create a path to the development and approval of cutting edge synthetic biology therapies.