The Security and Safety Implications of Cell-Free Systems for Biomanufacturing 

Organizations: University of Minnesota and Georgia Tech

In order to better inform policy and regulatory efforts, this project will analyze the security and safety implications of biomanufacturing using cell-free systems-based solutions. Cell-free platforms are already being used for research and development efforts like metabolic engineering and pathway discovery; applications for cell-free systems are growing to include large-scale bioproduction, biosensing, and bioremediation.  

After identifying the types of components most likely to be used in bioindustrial manufacturing applications of cell-free systems, researchers will investigate the potential for gene transfer between cell-free systems and live natural cells as well as evaluate the stability of cell-free systems in the environment. They will also identify the regulatory and policy landscape and ultimately create a database of cell-free systems viability in the environment with corresponding regulatory restrictions. In addition to the environmental conditions database, they will create a set of safety and security protocols and policy recommendations. Together, the experimental and safety data generated by this project will enable the development of cell-free systems to MRL7 and beyond, toward market applications. 

Project dates: 2024 – present

Funding source: BioMADE Project Call 4.0