Genezen, a cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has licensed the Cytegrity proprietary stable production system from biotechnology company CSL.
 
Cytegrity is an advanced inducible stable producer technology designed for the production of lentiviral vectors (LVVs). This technology is designed to allow for scalable and cost-effective generation of LVVs at clinically effective titers for both gene and cell therapies.
 
Lentiviral vectors are traditionally produced at limited scale using plasmid-based transient transfection technology. This stable lentiviral producer system offers continuous production from a stably transfected adherent or suspension cell line. This eliminates the need for costly plasmid, reduces process complexity, and allows for large-scale batch production, multiple harvests, and less batch-to-batch variability, thus significantly lowering production cost for Genezen’s clients.
 
Steve Favaloro, President and CEO of Genezen, commented, “I am excited that Genezen is the first CDMO to license the Cytegrity cell line. We have significant, hands-on experience scaling up and producing LVV using this stable production system at our GMP vector facility in Fishers, Indiana. Stable producer cell lines can be developed for clients in under four months, and this system will help alleviate the current global viral vector shortage by providing customers with a scalable, high quality vector platform. This licensing capability is a significant value-add for our current and future LVV customers, and furthers our collective mission to bring gene and cell therapies more efficiently to patients.”
 
Vicky Pirzas, SVP Biopharmaceutical Product Development at CSL, added, “We are excited to share access to the Cytegrity cell line with Genezen and the broader cell and gene therapy community including innovators and manufacturers. Following many years of investment in the development of the cell line at CSL in collaboration with our partners, the Cytegrity cell line will potentially lower cost of goods and enable quicker scaleup to clinical and commercial manufacture which, in turn, will benefit patients in gaining access to therapies faster.”
 
Genezen is prepared to begin immediately offering Cytegrity to customers at its GMP facility in Fishers, IN.