The Industrial Revolution for Cancer Therapy

Artificial intelligence instead of manual labor: Highly automated production aims to make CAR T-cell therapy affordable. An initial production platform already exists.

CAR T-cell therapy is a ray of hope in the dark chapter of cancer. But this new approach comes at a price: Manufacturers charge up to 400,000 euros for the production of individual gene-modified immune cells for people suffering from cancer. Until now, this treatment has only been approved for specific forms of leukemia and lymphoma. However, intensive research into CAR T-cell therapy means it could soon also be considered for other types of cancer, or could even be used preventively. That is good news for the afflicted, but is a financial burden for an already struggling healthcare system. Researchers at the Fraunhofer Institute for Production Technology IPT are therefore working together with the Fraunhofer Institute for Cell Therapy and Immunology IZI, companies and institutions from seven countries in the EU-funded AIDPATH project (AI powered, Decentralized Production for Advanced Therapies in the Hospital) to develop a system for the highly automated production of CAR T cells. A prototype laboratory platform for this has been in place at the University Hospital of Würzburg since the summer of 2025.

From the T cell to the finished product, ready to send

What previously had to be done manually by specialists is now done by the machine: “In the first step, the T cells are separated from the patient’s blood and activated so that they multiply,” explains medical engineer Bastian Niessing, head of the Bio-Adaptive Production department at Fraunhofer IPT and project coordinator. “In the next step, the appropriate CAR receptor is incorporated in the T cells. This is done either by using a virus or through electroporation, which electrically induces permeability of the cell membrane.” The CAR T cells are then multiplied in a bioreactor and finally harvested, purified, filled in vials and checked. The end product is already frozen and is thus ready for transport.

Not only does the high degree of automation reduce personnel costs in production, but also the error rate. Niessing: “Many of the activities involved in manually producing CAR T cells are highly repetitive and are therefore prone to errors. In contrast, the machine works around the clock at a consistent quality level.” The COPE software developed at Fraunhofer IPT makes the platform easy to operate.

The use of digital twin cells also enables AI-supported production planning. Artificial intelligence is used to optimize aspects such as the parameters in the bioreactor, ensuring that the cell cultures grow at the ideal rate and are harvested at the best possible time. “This ensures that I always get a patient-specific, high-quality and safe product, regardless of the number or quality of the cells at the start of the process,” explains Niessing. The AI is continuously improving through the integration of patient data, production parameters and therapy monitoring.

The CAR-T cells are not produced any faster with the production platform. “The process is biologically limited and takes two to three weeks,” explains Niessing. The scaling potential of the technology is therefore not one of speed, but rather of quantity over time. The prototype platform can already produce cells for up to twelve cancer patients in parallel. Fraunhofer IPT is also working with a licensee on a system that can produce up to 10,000 products per year. Niessing believes that, over the long term, this will reduce production costs by a third compared to manual production.

To what extent will this savings be reflected in the final price of CAR T-cell therapy? Niessing suspects that the therapy costs will level off at 150,000 to 200,000 euros, thus putting it at the price level of chemotherapy. This would already be a benefit for patients.