Genezen, a cell and gene therapy CDMO, has finished construction on an early phase clinical cGMP manufacturing facility, part of a planned 75,000 sqft lentiviral and retroviral process development and cGMP vector production facility in the US.
The company has 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 cell banking and vector manufacturing suites with an expanded GMP warehouse.
The decision to move quickly with the next phase has reportedly been driven by high demand from current and prospective clients, who Genezen says want its early-stage expertise paired with scalable manufacturing process and analytical development support for retroviral and lentiviral vectors.
Upon completion of the 75,000 sqft Indianapolis facility, the company will 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, it will expand its current GMP capabilities for host cell expansion and host cell banking.
Raymond Kaczmarek, CEO at Genezen, said: “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.”