Genezen, a cell and gene therapy CDMO specializing in lentiviral and retroviral vector manufacturing, completed construction of the early phase clinical cGMP manufacturing facility as a part of its master plan for a 75,000 ft2 process development and cGMP vector production facility in Indianapolis, IN.
Genezen also reported that the next phase of its expansion to support increased lentiviral and retroviral GMP vector demand 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.
At the completion of the new 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, according to company CEO Raymond Kaczmarket, CEO, who added that Genezen will expand its current GMP capabilities for host cell expansion and host cell banking.
“This is an exciting time for Genezen. I am 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,” he said. “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. Company officials say 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.
“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,” said Bill Vincent, executive chairman of the board at Genezen. “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.”