"Star Trek" for medicine: research wants CAR-T therapy directly in the hospital

Personalized cancer therapies such as CAR-T cell therapies are considered one of the greatest medical innovations of recent years. At the same time, they are expensive, time-consuming, and often only available in specialized centers. The EASYGEN project aims to change this. The aim is to develop a modular platform that enables the automated production of CAR-T cells directly in the hospital—faster, more efficient, and closer to the patient.

We spoke to Theresa Ahrens about the role of Fraunhofer IESE, the involvement of clinics, regulatory issues, and the use of digital twins. She holds a degree in molecular medicine, did her doctorate in Freiburg on epigenetic cancer therapies, and has headed the “Digital Health Engineering” department at Fraunhofer IESE since 2022.

Fraunhofer IESE is involved in the EASYGEN project. What exactly is it about?

The aim is to develop a modular and automated manufacturing platform that can be used to produce CAR-T cell therapies directly in hospitals. In the future, this should ensure that patients can be treated faster, closer to home, and more cost-effectively. Until now, the production of CAR-T cells has been centralized in accredited centers and takes four to six weeks. We now want to work with all project partners to develop a point-of-care platform that shortens all manual steps between blood cell collection and administration—and thus drastically reduces the manufacturing time to 24 hours.

If we succeed, we will have created the basis not only for making CAR-T therapies faster and cheaper but also for making them accessible to a larger number of patients.

How will the hospitals be involved?

Firstly, we want to ensure that the processes we develop can be embedded in everyday hospital life. That is why we are pursuing a user-centered approach and, for example, involving hospital staff throughout the entire project period. On the other hand, we need to set up a technical interface to existing hospital information systems (HIS). We are therefore examining how the digital twin can be docked. Above all, our department is working on making the solution compatible with common data standards such as FHIR, which is currently the most important standard in healthcare.

Does this mean that the solution is designed more for large centres?

Our aim is that the therapy can be integrated into different types of hospitals so that patients can be treated closer to home. Partners such as the Helios Klinik Berlin-Buch are already involved.

What regulatory hurdles are there?

This is a separate work package that our project partners are working on. As this type of “production in hospital” does not yet exist, we have to develop regulatory strategies from the outset and include the regulatory bodies in the planning of the experiments. This also involves preparations for subsequent clinical authorisation.

What is the biggest challenge for EASYGEN?

Clearly, the technology development. Conventional CAR-T production takes four to six weeks in highly specialized laboratories. Our goal is to transfer this complex process to a modular platform in the hospital that can potentially generate ready-to-use CAR-T cells within 24 hours. This is visionary—and for me personally, almost a bit “Star Trek.”

Are patients already being treated in the project?

No, that is not yet possible. So-called “dummy runs” with blood reserves and all affected groups of people are planned to simulate processes and check whether everything works. Clinical studies will only follow in later project phases.

What about IT implementation? Cloud or local?

Both are conceivable. Many hospitals prefer local solutions, but we design the digital twin so flexibly that both local and cloud approaches are possible—with high safety standards, of course.

You are also developing a "digital twin." What is it needed for in CAR-T cell therapy?

The digital twin is a central tool in the project for integrating the manufacturing process into the HIS. It virtually reproduces the production of CAR-T cells in the device and collects all relevant production and device data.

In short, the digital twin makes CAR-T production more transparent and easier to integrate into existing hospital IT systems. And it is an important component in relieving staff on site of manual documentation tasks.

What role does Fraunhofer IESE play in this?

Fraunhofer IESE has been heavily involved in the development of digital twins for Industry 4.0, but this has now become an international community. Standards such as the “Eclipse AAS approach” are ready for the market and are used in EASYGEN (Eclipse Foundation, Asset Administration Shell (AAS)).

There are also connections, for example, to the IDTA, which is driving forward the standardization of digital twins within Industry 4.0. We are also contributing our expertise in data interoperability and data structuring in the healthcare sector, as well as user-centered process design. Our aim is to ensure that all workflows relating to the new point-of-care platform do not burden employees but rather reduce their workload.

How big is the project consortium?

We have 18 partners under the consortium leadership of Fresenius, who are working together in nine work packages—from technology development and digitalization to regulation and cost-benefit analyses. Fraunhofer is involved with two institutes, Fraunhofer IESE in Kaiserslautern and Fraunhofer IZI in Leipzig and Würzburg.

(mack)