Lonza, a global leader in biological development and manufacturing, announced today that with the approval of CSL Behring’s IDELVION® fusion protein for Hemophilia B Therapy, the overall number of approved biotherapeutics expressed using our GS Gene Expression System™ now totals 25 products. IDELVION® is the third GS expressed product approved in 2016.
CSL Behring developed IDELVION® internally by taking advantage of our GS Licensing Program. They began their development work with a Research Evaluation Agreement using the materials and tools provided, such as Lonza’s proprietary CHO host cells, GS vectors, chemically defined animal component-free (CDACF) Media and Feeds, regulatory reports and technical operating manual that includes our platform manufacturing process.
This licensing program allows companies the flexibility of working in-house with a world-class expression and production technology, which can accelerate the development and production of their most-promising therapeutic candidates. The processes provided in our manual are based on the ones used within Lonza and create a seamless option for transfer to Lonza for development or manufacturing support.
“Since its introduction more than 20 years ago, we have continuously improved our GS System™,” said Shiva Khalafpour, Lonza’s Head of Licensing. “With more than 500 therapeutic products being developed under GS Licenses, it remains the gold standard for mammalian expression technology. In addition, our licensing program provides options that allow portability of the GS System™ for development and manufacturing from our customers to Lonza or to another strategic partner. This flexibility addresses the changing needs of a biopharmaceutical as it progresses through its development program.”