Fraunhofer Institute for Experimental Software Engineering IESEFraunhofer IESE supports EU-funded research project for the automated production of CAR-T cells at the patient's bedside
CAR-T therapy is a state-of-the-art cancer treatment in which cancer cells are recognized and destroyed with the help of the patient's own immune cells. The therapy is highly effective, but also involves a complex, lengthy and often manual production process that can currently only be carried out at a limited number of sites. The new EASYGEN research project is tackling this problem: Under the consortium leadership of Fresenius SE & Co. KGaA, a consortium consisting of 18 partners has joined forces with the aim of developing a fully automated, hospital-based platform that can be used to produce personalized CAR-T cell therapies within a few days and on site at the hospital.
The Fraunhofer Institute for Experimental Software Engineering IESE (Fraunhofer IESE for short) is one of the project partners and is taking on key tasks with regard to the technical development of the platform. The research project is being funded by the Innovative Health Initiative (IHI) with a total of eight million euros. The project is initially scheduled to run for five years.
How have CAR-T cell therapies been produced so far?
CAR-T therapies (chimeric antigen receptor T therapies) are produced individually for each patient. In a first step, white blood cells are taken from a patient. These are then sent to an accredited center where the cells are modified so that they can target specific proteins that are only found on the surface of cancer cells. The modified cells are then tested and expanded before being sent back to the hospital where they are administered to the patient by infusion.
The manufacturing process usually takes four to six weeks and during this time the patient requires a high level of monitoring, bridging therapy and care as their condition is at risk of deteriorating further. In addition, the delay between cell collection and administration means that some patients may not be prescribed CAR-T therapy at all. In fact, only less than 20 percent of eligible patients currently receive this therapy.
How does EASYGEN aim to revolutionize the manufacturing process?
EASYGEN aims to revolutionize CAR-T cell manufacturing by developing an automated, modular point-of-care cell and gene therapy platform that would enable hospitals to manufacture CAR-T cells on site - right at the bedside. The platform would automate all manual steps between the collection of blood cells and the administration of the modified cells, drastically reducing the manufacturing time to 24 hours. For hospital staff, this would drastically reduce the workload associated with CAR-T cell therapy. In terms of costs, EASYGEN expects the platform to cut treatment costs in half.
What is Fraunhofer IESE's role in the project?
The areas of responsibility of the Fraunhofer IESE research team vary from project phase to project phase. At the beginning, the research institute is increasingly involved in creating a sufficient information base. This includes, for example, listing the technical requirements for the manufacturing process at the patient's bedside. In addition, it is important to clarify how the modular platform can be optimally embedded in the processes within the hospitals. In addition, the requirements of all stakeholders in the project must be orchestrated.
At a later stage, Fraunhofer IESE will contribute its software expertise regarding the creation of standardized digital twins to the project. The digital twins will play a key role in the efficient and forward-looking development of the platform, but will also ensure interoperability with other systems in the hospital and/or laboratory. This will ensure that the solution developed in the project is compatible with the existing and future infrastructure.
"We at Fraunhofer IESE have many years of experience in the individualization of manufacturing processes. We will now apply this knowledge to the EASYGEN project and, together with the other project partners, take the production of CAR-T cell therapies to a completely new level. In the future, this form of therapy should no longer be available to just a few individual patients, but to everyone who needs it," explains Prof. Peter Liggesmeyer, Director of Fraunhofer IESE.
“EASYGEN brings together physicians, researchers and partner institutions from across Europe to work together to bring innovative, personalized therapies faster to where they are needed most - to patients,” says Dr. Sonja Steppan, Head of the Research Office at Fresenius SE and EASYGEN project leader. “The automation of patient-specific therapies such as CAR-T is crucial to making these treatments more widely available - especially in non-university clinics.”
About EASYGEN
EASYGEN is a five-year research project supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under Grant Agreement No. 101194710. The JU is supported by the European Union's Horizon Europe research and innovation program as well as COCIR, EFPIA, Europa Bío, MedTech Europe, Vaccines Europe and industry partners. The project, selected under the IHI call “User-centric technologies and optimized hospital workflows for a sustainable healthcare workforce”, aims to develop an integrated, automated platform that enables point-of-care CAR T-cell manufacturing, reducing production time, lowering costs and expanding access to next-generation immunotherapies.
Disclaimer: Funded by the European Union, IHI JU private members and contributing partners. However, the views and opinions expressed are solely those of the author(s) and do not necessarily reflect those of the parties mentioned. None of the aforementioned parties can be held responsible for them.
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