Fresenius and Charles River Laboratories are among 18 academic, research, industry and clinical partners that have formed a new European Union-supported consortium to develop an automated, hospital-based manufacturing platform for CAR-T cell therapies.
The consortium, dubbed EASYGEN (Easy Workflow Integration for Gene Therapy), is backed by €8 million ($9.3 million) in funding from the EU’s Innovative Health Initiative, Fresenius Kabi—the German drugmaker leading the effort—said in an Aug. 26 press release.
The EASYGEN consortium will set out to develop an automated, hospital-based production platform that can crank out CAR-T therapies in less than 24 hours and at a lower cost than current manufacturing approaches allow, according to multiple press releases from the group's members this week.
CAR-T therapies, which genetically engineer a patient’s T cells to identify and attack cancer cells, have faced numerous challenges since the 2017 debut of the class with Novartis' Kymriah, including significant manufacturing and scalability hurdles.
“The current manufacturing process for CAR-T therapies is time-intensive and severely limits their clinical application,” Julia Schueler, Ph.D., head of Charles River’s oncology unit, said in a statement. “By collaborating across industry and academia, I am hopeful we can design a streamlined workflow that will increase access to these therapies for patients who need them.”
The consortium’s proposed bedside manufacturing platform will leverage technology originally developed by the cell and gene therapy unit of Fresenius' Fresenius Kabi, as well as Charles River’s 3D screening technologies and Cellix’s Inish Analyser, which measures cell viability and cell numbers to monitor safety and quality.
“The aim is not only to develop cutting-edge medical technologies, but also to make them available quickly, safely, and close to the patient,” Christian Hauer, Ph.D., Fresenius Kabi's medtech president, said in a statement. “In this way, we are actively working to shape the healthcare of tomorrow.”
In Europe, access to CAR-T therapies is currently limited despite many patients qualifying for the treatments, the group said. Citing a report from IQVIA, Fresenius noted that the average treatment rate spanning five countries in the region is currently below 20%. That number is slightly higher at 30% in France, while it drops to just 11% in Italy.
“Automation can help reduce production complexity of these therapies, with the aim of making it easier to scale these life-saving treatments and improve patient access,” said Ralf Kuhlen, chief medical officer at Fresenius.
Aside from Fresenius and Charles River, other members of the EASYGEN consortium include: Helios Hospital Berlin-Buch, Quirónsalud, Fenwal, Pro-Liance Global Solutions, TQ Therapeutics and Philips Electronics.
The group also includes a number of academic and research institutions, such as Fraunhofer IESE; Fraunhofer IZI; Helmholtz-Zentrum Dresden-Rossendorf; Technical University of Denmark; Frankfurt School of Finance & Management; European Society for Blood & Marrow Transplantation; Bar-Ilan University; University of Glasgow; and the University of Navarra.