Licensing of a proven stable producer system for lentiviral vector production represents a significant investment in next-generation technology for Genezen, offering its clients immediate access to cutting edge technology for stable and scalable high-titer clinical lentivirus production.
FISHERS, IN. and BOSTON, MA – Feb. 21, 2024 – Genezen, a leading cell and gene therapy Contract Development and Manufacturing Organization (CDMO), today announced licensing of the Cytegrity™ proprietary stable production system from biotechnology leader CSL.
Cytegrity™ is an advanced inducible stable producer technology designed for the production of lentiviral vectors (LVVs). This cutting-edge technology allows for scalable and cost-effective generation of LVVs at clinically effective titers for both gene and cell therapies. Validated through early clinical testing, Cytegrity™ has demonstrated safety and efficacy. Lentiviral vectors are traditionally produced at limited scale using plasmid-based transient transfection technology. This stable lentiviral producer system is one of the first of its kind to offer 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.”
Pratima Cherukuri, CSO of Genezen, also commented, "I am enthusiastic to drive the field forward by optimizing LVV production for speed, cost-effectiveness, scalability, and reproducibility. Leveraging our experience and expertise with Cytegrity™, I believe that Genezen can truly help customers get to the clinic faster and producer higher quality LVV at scale in the long run.”
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 state-of-the-art GMP facility in Fishers, IN – please contact Jennifer Thiaville at jthiaville@genezen.com.
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