Charles River Laboratories International has joined the EASYGEN (Easy Workflow Integration for Gene Therapy) Consortium, a European Union-backed initiative designed to revolutionize CAR-T cell therapy manufacturing by enabling fully automated, hospital-based production within 24 hours. The five-year research project, funded by the Innovative Health Initiative Joint Undertaking under grant agreement No 101194710, brings together 18 leading academic, research, industry and clinical partners across eight countries.
Addressing Critical Manufacturing Bottlenecks
CAR-T cell therapy represents a breakthrough in cancer treatment, yet fewer than 20 percent of eligible patients currently receive it. These therapies typically involve genetically modifying a patient's T cell to target cancer, requiring complex, time-intensive production in specialized facilities often far from patients. Limited manufacturing capacity and supply chain delays prevent timely patient access.
"In the treatment of complex cancers, time is critical," said Julia Schueler, DVM, PhD, Therapeutic Area Lead, Oncology, Charles River. "The current manufacturing process for CAR-T therapies is time-intensive and severely limits their clinical application. 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."
Charles River's Technical Contribution
Charles River will leverage its deep institutional expertise in 3D screening technologies to develop an ex vivo platform to expedite early screening for safety and efficacy. By leveraging access to Charles River's well-annotated patient-derived xenograft (PDX) bank in combination with high-content imaging read-outs, the new 3D screening platform will enable the rapid identification of the safest and most efficacious CAR-T cell candidate for subsequent development.
Market Impact and Growth Potential
The global CAR T-cell therapy market was valued at $4.65 billion in 2024 and is expected to grow at a compound annual rate of 22.2% through 2030, according to Grand View Research. The rising cases of cancer malignancies continue to fuel the market for CAR T-cell therapy, with multiple product launches and approvals giving market players significant traction.
Consortium Goals and Innovation
"EASYGEN unites physicians, researchers, and partner institutions across Europe to collaboratively deliver innovative, personalized therapies more swiftly to where they matter most—to patients in need," said Dr. Sonja Steppan, Head of Research Office, Fresenius SE and Principal Investigator, EASYGEN. "Automating patient-specific therapies such as CAR-T is essential to make these treatments more broadly accessible, especially in non-academic clinical environments."
The EU's Innovative Health Initiative's Call 7, Topic 2, introduced in 2024, focuses on the development of user-centered technologies to relieve hospital staff and broaden access to advanced treatments. The EASYGEN Consortium aims to meet this goal by enabling rapid, in-hospital CAR-T cell production in days rather than weeks, accelerating patient access, reducing workloads, and lowering costs.
