Genezen, 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 officially opened its new process development and analytical lab.
The lab will deliver a full suite of 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.
The lab is the first phase of a multiphase master plan for a 75,000+ square foot cGMP-compliant lentiviral and retroviral vector production facility. The next phase, with cGMP production suites, is currently underway and due to complete in early 2022.
“The opening of our dedicated viral vector process and analytical development lab is a key milestone for us in launching our additional early-stage capabilities needed to drive the cell and gene therapy industry forward,” said Ray Kaczmarek, Chief Executive Officer at Genezen.
“Our deep expertise in development and manufacture of viral vectors coupled with this new facility and equipment will accelerate our partners’ abilities to advance life-saving therapies into the clinic.”
Once finished, the state-of-the-art facility will deliver aseptic manufacturing of lentiviral and retroviral vectors from multiple cGMP production suites and will offer capabilities for host cell expansion, host cell banking, and viral vector production via transient transfection and producer cell lines.
Analytical testing services, including Recombinant Competent Lentivirus (RCL) testing, vector stability testing, and safety and sterility testing, will also be available from the site.
The end-to-end capabilities will facilitate Genezen’s delivery of optimized closed and semi-automated processes for viral vector production.
Genezen will continue to provide cell manufacturing and patient sample testing through its existing academic partnerships.
Construction of the new facility has been funded by a majority investment from Ampersand Capital Partners, a private equity firm specializing in growth equity investments in the healthcare sector.