GBIO - Generation Bio plans to scale RES manufacturing process across portfolio

Generation Bio (GBIO) plans to deploy next-generation rapid enzymatic synthesis ((RES)) for manufacturing of its closed-ended DNA (ceDNA) constructs across all portfolio programs. The company has signed a lease agreement to build out a state-of-the-art cGMP facility of approx. 104,000 square feet in Waltham, Mass. to scale RES for clinical and initial commercial supply.The facility is expected to be operational in 2023, enabling an IND application and clinical development for the company’s lead hemophilia A program.Generation Bio is using existing infrastructure for RES production of research material. The company anticipates incurring net lease costs of $104M over a 12-year period and investing up to $45M in the new manufacturing facility over the next two years. GBIO is currently advancing its liver-directed, cell-targeted lipid nanoparticle delivery system with RES for the lead hemophilia A program. It expects to report factor VIII expression data using RES-produced drug product in non-human primates by year-end.

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Generation Bio plans to scale RES manufacturing process across portfolio