Generation Bio Announces Update to Its GMP Manufacturing Strategy
Company projects smaller GMP manufacturing footprint, enabled by further process development of rapid enzymatic synthesis of ceDNA at scale
Company will seek to sublease its planned GMP facility, and will adopt a more capital efficient, modular, and flexible manufacturing approach
Capital reallocated from facility buildout expected to extend cash runway into 2025
Cambridge, Mass. – June 21, 2022 – Generation Bio Co. (Nasdaq: GBIO), a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, announced that it is updating its Good Manufacturing Process (GMP) manufacturing strategy to integrate efficiencies enabled by improvements to its proprietary rapid enzymatic synthesis (RES) 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.
“The productivity, yield and short cycle time of our RES process at scale is expected to allow us to supply our portfolio through the next 10 years with a much smaller, flexible manufacturing footprint,” said Antoinette Paone, chief operating officer of Generation Bio. “Since we anticipate no impact to timelines with this shift, we believe it is prudent to pursue a more operationally and financially efficient GMP manufacturing strategy.”
By opting not to continue with the facility buildout, the company estimates an extension of its cash runway into 2025. The change in manufacturing strategy is not expected to affect production of ceDNA for Generation Bio’s ongoing research on its liver, retina and vaccine programs.
About Generation Bio
Generation Bio is innovating genetic medicines to provide durable, redosable treatments for people living with rare and prevalent diseases. The company’s non-viral genetic medicine platform incorporates a novel DNA construct called closed-ended DNA, or ceDNA; a unique cell-targeted lipid nanoparticle delivery system, or ctLNP; and a highly scalable capsid-free manufacturing process that uses proprietary cell-free rapid enzymatic synthesis, or RES, to produce ceDNA. The platform is designed to enable multi-year durability from a single dose, to deliver large genetic payloads, including multiple genes, to specific cell types, and to allow titration and redosing to
