Pharma Focus Asia

Lineage Establishes New R&D Facility in U.S. and Expands Current GMP Manufacturing Facility in Israel

Tuesday, October 04, 2022

Lineage Cell Therapeutics, Inc., a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today the opening of a new research and development (R&D) facility in Carlsbad, California, and the expansion of its Good Manufacturing Practice (GMP) manufacturing facility based in Jerusalem, Israel. Lineage’s new Carlsbad facility will broaden the Company’s R&D capabilities in the U.S. and support the development of current and future allogeneic cell transplant programs. The expansion of Lineage’s Israel-based facility will increase the Company’s infrastructure, including development and optimization of larger-scale clinical manufacturing processes, and continued execution under its ongoing collaboration with Roche and Genentech for RG6501 (OpRegen®), a retinal pigment epithelium cell replacement therapy which has completed enrollment in a Phase 1/2a clinical trial for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

“We have elected to increase our R&D footprint at our existing GMP manufacturing facility and establish a new R&D facility in Carlsbad, California,” stated Brian M. Culley, Lineage CEO. “These steps will permit us to expand our process development and analytical testing capabilities and conduct exploratory work on future programs, whether owned by us or our current or future partners. This move also is expected to reduce our reliance on certain vendors, which may reduce costs and risks of timeline uncertainty or supply chain disruption. The additional capacity also can help us become an even more capable partner in prospective alliances for new products and allow us to explore additional uses for our current cell transplant programs.”

Mr. Culley added, “Challenges in the biotech sector are unlikely to persist indefinitely. We believe it is important to take steps, even in this environment, to be positioned for a future recovery. The modest investments we are making today, partially offset by the termination of the lease for our research facility in Alameda, California in January of next year, will help centralize our operations and put us in a position of greater readiness for future success.”

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