The manufacturing center will be staffed initially by 30 employees, according to the companies, and will be prepared to produce OpRegen for BioTime’s ongoing clinical trial program evaluating the cell therapy as a treatment for dry age-related macular degeneration.
“The opening of this new, innovative manufacturing center, demonstrates our continued commitment and is the culmination of a multi-year effort by BioTime and its subsidiary, Cell Cure Neurosciences, to manufacture cell therapies in Israel on an industrial scale,” the company’s co-CEO Adi Mohanty said in prepared remarks. “Near term, this new center will manufacture OpRegen doses to treat the patients enrolled in the clinical trial program. Longer term, this center may manufacture additional cell therapies as our products progress into clinical trials and then into commercial distribution.”
“The opening of this new manufacturing center is an exciting and important development. Our team in Israel together with BioTime is advancing the OpRegen clinical trial program and the manufacture of OpRegen,” Cell Cure Neurosciences CEO Charles Irving added. “We look forward to continued close collaboration with BioTime as it advances additional cell therapy programs in the near future.”
BioTime’s OpRegen therapy provides retinal pigment epithelial cells to the retina, replacing those lost to dry AMD. The company touted data last month that demonstrated the therapy’s safety and showed the presence and survival of transplanted cells in the subretinal space for up to 1 year.