Genezen completes cGMP clinical production facility buildout

Genezen, a cell and gene therapy CDMO specialising in lentiviral and retroviral vector manufacturing, has completed construction of the early phase clinical cGMP manufacturing facility.

This facility is part of the overall plan for a 75,000 sq ft lentiviral and retroviral process development and cGMP vector production facility in Indianapolis, Indiana, US. 

Genezen also announced the next phase of its expansion to support increased lentiviral and retroviral GMP vector demand, which will include additional process development, analytical development, and quality control labs as well as GMP cell banking and GMP vector manufacturing suites with an expanded GMP warehouse.

The decision to move quickly with the next phase has been driven by high demand from current and prospective clients wanting early-stage expertise paired with scalable manufacturing process and analytical development support for retroviral and lentiviral vectors.

At the completion of the 75,000 sq ft facility, Genezen will further increase delivery of cGMP lentiviral and retroviral vectors with adherent and suspension processes supporting both transient transfection and producer cell line vector manufacturing platforms. Additionally, Genezen will expand its current GMP capabilities for host cell expansion and host cell banking. 

Raymond Kaczmarek, chief executive officer at Genezen, commented: “This is an exciting time for Genezen. I am very proud of our team as they worked diligently with our key contractors, suppliers, and consulting specialists to make this a reality in a short period of time. 

“With this phase being complete, we are now focused on delivering cGMP vectors for our clients in the coming weeks and well into the future.”  

The construction of Genezen’s expanded lentiviral and retroviral process development and analytical lab was completed in December 2021. 

The lab delivers 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. Testing services including Recombinant Competent Lentivirus (RCL), vector stability, safety and sterility are also available.

Bill Vincent, executive chairman of the board at Genezen, added: “A decade ago there wasn’t much of a cell and gene industry to speak of, but it's grown incredibly fast, and the number of approved therapies is now well into double figures. There is a continued need for capacity and expertise and given the current growth estimates combined with the potential of these therapies, this demand is going to rapidly increase.

“Our intent is to meet the needs of our clients, both now and in the future, which is why we are moving forward quickly with this next phase of expansion. We have been actively engaging with our existing clients throughout the buildout to ensure we are meeting their needs and will continue to do so as we implement this next exciting phase of our plans.”   

The construction of the new facility has been funded by a majority investment from Ampersand Capital Partners, a private equity firm specialising in growth equity investments in the healthcare sector.