The Switch to Cell-Free DNA | Strategic and regulatory considerations

Quick reference

Gene and cell therapy manufacturers are increasingly transitioning from plasmid DNA to cell-free DNA as a critical starting material. The benefits are clear: faster production, improved safety profiles, and greater flexibility for complex sequences.

The challenge? Demonstrating regulatory comparability between your old and new processes.

This quick reference guide outlines the key advantages of cell-free DNA, explains what "comparability" means to regulatory agencies, and provides a practical roadmap for your transition—from risk assessment and analytical testing to regulatory submission strategies.