Generation Bio Co. announced that it is updating its Good Manufacturing Process manufacturing strategy to integrate efficiencies enabled by improvements to its proprietary rapid enzymatic synthesis process for the production of closed-ended DNA (ceDNA). RES is a cell-free process that delivers three key benefits compared to biologics-based DNA manufacturing approaches: consistent yields of highly pure ceDNA, potential to scale to hundreds of millions of doses, and short production cycles.

In July 2021, Generation Bio announced plans to deploy RES for ceDNA across all of its portfolio programs and had entered into a lease agreement to build out a GMP facility in order to scale RES for clinical and initial commercial supply. Through further process development of RES, the company has achieved a significant increase in scale while maintaining high productivity and ceDNA purity, and now projects underutilization of the planned GMP facility. The company will seek to sublease this facility and intends to execute an alternative GMP approach that retains control over personnel, quality, infrastructure and process know-how.