Genezen Laboratories, a cell and gene therapy Contract Development and Manufacturing Organization (CDMO) focused on early-phase process development, vector production and analytical testing services, has broken ground on a new multiphase master plan for a 75,000 sqft cGMP-compliant Lentiviral vector production facility.
The first phase will see the construction of a 25,000 sqft site which will include a process development lab expansion, scheduled for completion in Autumn 2021.
The lab will facilitate Genezen's delivery of its optimised closed and continuous processes for viral vector production. The remaining buildout phases of the facility will complete in early 2022.
The investment builds on Genezen's expertise in lentiviral and retroviral vector production and early-phase development of cell therapy products, so the company can help current and future clients initiate and continue to supply early phase clinical trials.
Bill Vincent, Chairman and CEO of Genezen, said: "Building on recognised expertise in lentiviral and retroviral vector platforms, and leveraging the CDMO experience of our investor Ampersand, we are investing heavily to meet this need now, and in the future."
Vincent added: "Our new facility will support clients with the latest technologies as they develop and deliver life-changing therapeutics to patients."
Partnering with DPS
Genezen has partnered with DPS Group, a global engineering, procurement, construction management and validation firm, to build the state-of-the-art facility for the aseptic manufacture of lentivirus vectors. The facility will include multiple cGMP production suites including 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 and provides the ideal presentation for use in cell therapy.
Genezen will also deliver a full suite of 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 from the site.
Analytical testing services, including Recombinant Competent Lentivirus (RCL) testing, vector stability testing, and safety and sterility testing, will also be available.
