Contract development and manufacturing organisation (CDMO) Genezen has announced plans to license CSL’s Cytegrity stable lentivirus production system.
The advanced inducible technology produces lentiviral vectors (LVVs), which are vital for gene and cell therapies.
The Cytegrity technology enables scalable and cost-efficient production of LVVs at clinically efficient titers.
It has shown promising safety and efficacy results and is validated through early clinical testing.
LVVs are generally manufactured on a small scale leveraging plasmid-based transient transfection technology.
The Cytegrity system represents a significant advancement and is one of the first to facilitate continuous manufacturing from a stably transfected adherent or suspension cell line.
This innovation alleviates the requirement for expensive plasmid inputs, reduces the complexity of the process and enables large-scale batch manufacturing.
It also offers the potential for multiple harvests and reduced batch-to-batch variability to cut down production expenditures for Genezen's clients.
Genezen's licensing of the Cytegrity system marks a substantial investment in next-generation technology for LVV production.
The strategic move will provide its clients with immediate access to pioneering technology for stable and scalable high-titer clinical lentivirus production.
The company is ready to provide the Cytegrity technology to its customers at its good manufacturing practice (GMP) facility in Fishers, Indiana, US.
Genezen president and CEO Steve Favaloro said: “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.”
