Genezen breaks ground on cGMP lentiviral vector production facility

By Jane Byrne contact

- Last updated on GMT

© GettyImages/metamorworks
© GettyImages/metamorworks

Related tags: Viral vector, lentiviral vector, Cell line, CDMO

Genezen Laboratories, Inc, a US cell and gene therapy contract development and manufacturing Organization (CDMO) is set to build a 75,000+ square foot cGMP-compliant lentiviral vector production facility in Indianapolis.

The CDMO is focused on early-phase process development, vector production and analytical testing services.

Bill Vincent, chairman and CEO of Genezen, said 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.”

Genezen started out by partnering with academic vector production facilities to utilize their excess production capacity. “We are now expanding into a stand-alone facility while continuing our academic partnerships,”​ Vincent told BioPharma-Reporter.

The CDMO will continue to provide cell manufacturing and patient sample testing through those academic alliances.

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.

The costs of the project were not disclosed though.

Continuous processes for viral vector production 

Genezen is partnering with DPS Group on the build. 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 facility, it said, 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.

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.

“We already have many of those capabilities, but the new space will expand capacity and be operational by September 2021,”​ said the CEO.

In terms of capacity for viral vector production when the facility is fully operational, he said: “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.”​ 

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