The deal with fellow Swiss firm Cytos Biotechnology provides Lonza with a system that can take several months off the 18 or so months required to make clinical supplies of a protein via conventional methods, accelerating its development programme.
Lonza has already developed its own glutamine synthetase (GS) gene expression system to create high yielding stable cell lines for large scale manufacturing, but the Cytos system will also allow it to make products for early clinical development before production cell lines for long-term use are available.
Cytos' mammalian expression system carves six to nine months off the time it takes to supply clinical trial material by doing away with the lengthy cell cloning steps needed to generate stable transfected cell lines that are currently used in protein manufacturing.
Wolfgang Renner, Cytos' chief executive, told In-Pharmatechnologist.com that Cytos' technology is a stable, proprietary transfection vector that can be used to engineer cells to make the desired protein. Because it is so stable, there is no need to identify a single clone that shows a high degree of protein expression; all the cells can be used to produce protein batches.
Under the terms of the agreement, Lonza has been granted a sole licence to manufacture therapeutic proteins for preclinical studies, clinical trials and in-market supply, as well as the right to sublicense the technology to its customers. Cytos retains the rights to its expression technology for production and commercialisation.
In return for a one-off license fee, Lonza has committed to develop a manufacturing process for GMP material using the system. If this is successful, Cytos can earn a development milestone, annuallicence fees, and royalties on Lonza protein sales and technology sublicensing revenues.
The benefit for Lonza is that it could potentially offer its customers earlier clinical supplies than its competitors, as well as a saving of half a year on development time, which can be as long as 10 years for a biopharmaceutical. This could have a significant impact in terms of getting to market early, as well as extending the patented lifespan of a product, noted Dr Renner.