Genezen begins construction of cGMP lentiviral production facility

The investment will provide capacity to support current and future demands for the rapidly evolving cell and gene therapy sector

Phase one — the construction of a 25.000-sq. ft site — includes a process development laboratory expansion to facilitate delivery of the company's optimised closed and continual processes for viral vector production.

In addition, the facility's multiple cGMP production suites will include capabilities for host cell expansion, host cell banking, and viral vector production via transient transfection and producer cell lines. The vector product will be aseptically filled into sterile bags, providing the ideal presentation for use in cell therapy.

From the site, which is located north of Indianapolis in Fishers, IN, Genezen will also deliver complementary process development capabilities to support cGMP and commercial readiness, upstream and downstream process improvements, research-grade and preclinical vector production, and analytical assay development and validation. Recombinant competent lentivirus (RCL) testing, vector stability testing, and safety and sterility testing, will also be available.

The CDMO expects to complete phase one in Autumn this year, and the rest of the buildout phases in early 2022.

The "heavy" investment builds on Genezen's expertise in lentiviral and retroviral vector production and early-phase development of cell therapy products, placing the company in a strong position to meet future demand.

Bill Vincent, Chairman and CEO of Genezen, commented: "Our new facility will support clients with the latest technologies as they develop and deliver life-changing therapeutics to patients.”