Genezen Laboratories, Inc., 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+ square foot cGMP-compliant Lentiviral vector production facility.
The first phase will see the construction of a 25,000 square feet site which will include a process development lab expansion, scheduled for completion in Autumn 2021. The lab will facilitate Genezen’s delivery of its optimized 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 commented, “The cell and gene therapy sector is evolving rapidly, and there’s growing demand for capacity and expertise. Building on recognized 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. Our new facility will support clients with the latest technologies as they develop and deliver life-changing therapeutics to patients.”
Genezen 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.
The new facility is being funded by a majority investment from Ampersand Capital Partners, a private equity firm specializing in growth equity investments in the healthcare sector.
David Anderson, General Partner at Ampersand, added “I am confident that our partnership will help Genezen to better serve its customers as the company builds out its infrastructure and service offering, to complement the deep expertise of its people. We believe that Genezen will fast become a market leader in cGMP manufacturing of lentiviral vectors for the cell and gene therapy sector – it’s an incredibly exciting prospect in a revolutionary healthcare market that is set to grow for years to come.”
Genezen will continue to provide cell manufacturing and patient sample testing through its existing academic partnerships.