The European Society for Blood and Marrow Transplantation (EBMT) has joined forces with a consortium of leading academic and industry partners from across Europe and beyond to revolutionize CAR-T cell therapy. This innovative collaboration, named EASYGEN (Easy workflow integration for gene therapy), aims to decentralize the production of personalized CAR-T cell therapies by developing a fully automated platform capable of manufacturing these therapies directly within hospital settings. Spearheaded by Fresenius SE & Co. KGaA and backed by an €8 million investment from the European Union, EASYGEN seeks to transform the current landscape of adoptive cell therapies by making them faster, more affordable, and widely accessible to patients who desperately need them.
CAR-T cell therapy represents a cutting-edge immunotherapy that harnesses the patient’s own immune system to recognize and destroy cancer cells by genetically reprogramming T lymphocytes. Despite its clinical promise, adoption of CAR-T therapy has been hampered by logistical barriers. Traditional manufacturing is centralized in specialized, highly regulated facilities remote from hospitals, resulting in production timelines of several weeks that delay clinical intervention. Furthermore, limited manufacturing capacity and supply chain inefficiencies restrict the number of patients who can receive this life-saving treatment annually. The EASYGEN consortium endeavors to overcome these hurdles by developing an integrated, hospital-based automated manufacturing system that reduces production timelines from weeks to just days.
This paradigm shift in CAR-T therapy production relies on advanced bioengineering, automation, and process analytics. By leveraging Fresenius Kabi’s pioneering technologies in cell and gene therapy, the EASYGEN platform will seamlessly incorporate patient cell harvesting, genetically modifying T cells to express chimeric antigen receptors, and expanding the engineered cells before release for reinfusion. Automated quality control and real-time monitoring are critical to ensure safety, efficacy, and regulatory compliance in a decentralized setting. This technology promises to alleviate the workload on skilled hospital staff who traditionally manage labor-intensive manual processes while simultaneously expanding access to next-generation immunotherapies.
The impact of decentralized CAR-T manufacturing extends beyond speed and efficiency. By situating production closer to the patient, EASYGEN aims to enhance treatment equity by overcoming geographic disparities that currently prevent many eligible patients from receiving therapy. Approximately 80% of patients who qualify for CAR-T treatment do not get access today due to capacity constraints and logistical complexity. Accelerating production and simplifying workflows will reduce healthcare costs, easing the burden on payers and health systems struggling with the high prices of these therapies.
Within the consortium, the EBMT brings critical expertise from its extensive knowledge base in transplant complications, cellular therapy, and immunobiology. EBMT’s involvement includes conducting an in-depth literature review assessing the quality of life outcomes for patients treated with current CAR-T delivery models, providing invaluable data to optimize patient experience and clinical support services. Furthermore, the society’s Patient Advocacy Committee will enhance education and outreach to ensure patients and healthcare providers are well-informed about the evolving treatment landscape.
The scientific leadership of EASYGEN is anchored by the Fraunhofer Institute IZI in Leipzig, regarded as one of Europe’s premier centers for immunotherapy research. The project is co-led by Prof. Dr. Michael Hudecek, a recognized authority in CAR-T cell engineering, whose research has been instrumental in advancing the functionality and safety of receptor constructs. Prof. Dr. Ulrike Köhl, a trailblazer in translational cellular immunotherapies, also guides the project’s scientific vision, ensuring rigorous preclinical and clinical development pathways.
EASYGEN encompasses eighteen partner organizations from eight countries, drawing on the strengths of industry leaders such as Fresenius SE & Co. KGaA, Helios Hospital Berlin-Buch, Fenwal Inc., and Philips Electronics Nederland B.V., alongside top academic institutions including Bar-Ilan University, the University of Glasgow, the Technical University of Denmark, and the University of Navarra. This multidisciplinary coalition ensures a comprehensive approach to technological innovation, clinical integration, regulatory strategy, and market adoption.
The central ambition of EASYGEN is to deliver a point-of-care CAR-T manufacturing platform that democratizes access and expedites time-to-treatment. By automating complex molecular and cellular processes and embedding manufacturing within routine hospital workflows, this initiative aligns with the objectives of the European Union’s Innovative Health Initiative. The project consortium is funded through grant agreement No 101194710 under the Horizon Europe program, supported additionally by industry associations like EFPIA, MedTech Europe, and Vaccines Europe.
Technically, the EASYGEN platform will integrate closed-system bioreactors, gene-editing technologies, and robust digital controls to ensure repeatable and scalable production cycles with real-time quality assessment. Such platform autonomy minimizes human error and logistical delays, transforming the manufacturing footprint for CAR-T therapies. Moreover, the platform’s modular design intends to accommodate a broad range of CAR designs and indications, enhancing its adaptability to emerging clinical needs.
The benefits of EASYGEN’s approach proliferate across the cancer immunotherapy ecosystem. Shortening manufacturing timelines will allow physicians to intervene swiftly against aggressive malignancies, potentially improving patient response rates and survival outcomes. The reduction in manufacturing costs may also stimulate healthcare payers to expand reimbursement policies, thus broadening patient eligibility. Finally, by simplifying workflows, healthcare providers can allocate resources more effectively, addressing staff shortages and reducing burnout in increasingly pressured hospital environments.
Patient-centeredness remains at the heart of EASYGEN’s vision. Alongside technology development, the consortium emphasizes patient education, informed consent processes, and advocacy to empower individuals navigating complex treatment decisions. The EBMT’s role in this dimension is vital, leveraging its patient registry and clinical networks to gather real-world data and feedback that will refine clinical practices and enhance patient satisfaction.
In the grander scheme of personalized medicine, EASYGEN exemplifies a trend toward decentralization and automation, bringing sophisticated cellular therapies from specialized laboratories directly into care delivery sites. This model not only expedites access but also enhances treatment customization by enabling iterative process improvements within hospital settings responsive to patient-specific needs. As the field moves toward next-generation immunotherapies, EASYGEN sets a crucial precedent for technological integration, regulatory harmonization, and clinical care innovation.
In conclusion, the EASYGEN consortium heralds a transformative era for CAR-T cell therapy by bringing cutting-edge manufacturing to the hospital bedside. By combining academic excellence, industrial innovation, and patient advocacy, this initiative stands poised to overcome existing barriers in the delivery of cellular immunotherapies. With its successful realization, EASYGEN will reshape oncology care paradigms, offering renewed hope to thousands of patients battling cancers that have traditionally eluded effective treatment.
Subject of Research: Development of a fully automated, hospital-based platform for decentralized CAR-T cell therapy manufacturing.
Article Title: EBMT Partners in Consortium to Revolutionize Decentralized CAR-T Cell Therapy Manufacturing
News Publication Date: 26th August 2025
Web References:
- https://www.ebmt.org
- https://x.com/TheEBMT
- https://www.linkedin.com/company/theebmt/
- https://www.facebook.com/TheEBMT
- https://www.youtube.com/user/theebmt
Keywords: Gene therapy, Chimeric antigen receptor therapy, Cancer treatments
