CSL Licenses Cytegrity Lentiviral Vector Production System to Genezen

Genezen, a cell and gene therapy contract development and manufacturing organization (CDMO), announced on Feb. 21, 2024 that it has entered into a licensing agreement with biotechnology company CSL for CSL’s proprietary stable lentiviral vector (LVV) production system, Cytegrity, which Genezen will implement in its Fishers, Ind., facility.

The system allows for scalable and cost-effective generation of LVVs at clinically effective titers for both gene and cell therapies, according to a company press release. Cytegrity is validated through early clinical testing and has demonstrated safety and efficacy. Traditionally, LVVs are produced at limited scale using plasmid-based transient transfection technology. Cytegrity offers continuous production from a stably transfected adherent or suspension cell line, which eliminates the need for costly plasmid, reduces process complexity, and allows for large-scale batch production. The system also allows for multiple harvests and less batch-to-batch variability, according to the press release.

"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 [good manufacturing practice] vector facility in Fishers, Indiana,” said Steve Favaloro, president and CEO of Genezen, in the release. “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."

"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," said Vicky Pirzas, senior vice-president, Biopharmaceutical Product Development, CSL, in the release.

Source: Genezen