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Genezen has opened its new process development and analytical lab for viral vector production.
Genezen, a cell and gene therapy contract development and manufacturing organization, has officially opened its new process development and analytical lab for viral vector production, the company announced in a Dec. 3, 2021 press release.
The lab includes a full suite of process development capabilities to support current good manufacturing practice (CGMP) and commercial readiness, upstream and downstream process improvements, research-grade and preclinical vector production, and analytical assay development and validation.
This lab is the first phase of a multiphase master plan to build an over 75,000-ft2 CGMP-compliant lentiviral and retroviral vector production facility. The next phase includes CGMP production suites, construction of which is currently underway and due to be complete in early 2022.
When finished, the new facility will conduct 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 using transient transfection and producer cell lines. The site will also include analytical testing services, such as recombinant competent lentivirus testing, vector stability testing, and safety and sterility testing. The facility’s end-to-end capabilities will enable Genezen to deliver optimized closed and semi-automated processes for viral vector production.
Genezen will meanwhile continue providing cell manufacturing and patient sample testing through its existing academic partnerships.
“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, CEO of Genezen, in the press release. “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.”