The next phase, with cGMP production suites, is currently underway and due to complete in early 2022.
The lab, said the CDMO, 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.
In June, Genezen told us the cell and gene therapy sector is evolving rapidly, and there is growing demand for capacity and expertise. “We are investing heavily to meet this need now and in the future.”
The CDMO started out by teaming up with academic vector production facilities to utilize their excess production capacity, and will continue to provide cell manufacturing and patient sample testing through such alliances. “We are now expanding into a stand-alone facility while continuing our academic partnerships.”
The new facility, which will have a global focus in terms of target clients, is being funded by a majority investment from Ampersand Capital Partners, a private equity firm specializing in growth equity investments in the healthcare sector.
Cell expansion, banking
Once finished, the site 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.
In terms of capacity for viral vector production when the facility is fully operational, the company told us previously: “Capacity is difficult to define because of the variability between client vectors and the production platform the client chooses to use, but we will be continuing to grow with our client's needs.”