New directions in cancer treatment

CAR-T cells: Individually Customized Immunotherapies

CAR-T cell therapies activate the body’s own immune system to fight cancer. This involves modifying the patient’s own immune cells to recognize specific features of cancer cells. Fraunhofer is working jointly with partners to develop technologies and processes that support faster, standardized and cost-effective CAR T-cell manufacturing while facilitating the application of new therapeutic approaches in clinical practice.

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Background: What are CAR-T cells?

CAR-T cells (CAR = chimeric antigen receptor) are genetically modified immune cells used to fight certain cancers and autoimmune diseases. The modification equips T cells with a receptor that recognizes and binds to specific antigens on cancer cells, triggering a targeted immune response. Approved CAR-T cell therapies currently target antigens CD19 and BCMA, which are associated with hematologic cancers such as leukemia and lymphoma.
 

Note: Fraunhofer and its partners research and develop new therapies and facilitate their clinical application. Decisions on the approval of new drugs rest with the competent regulatory authorities.

 

CAR-T cells—“living medicine”

Mobilizing the body’s own immune system

CAR-T cells are a patient’s own immune cells that can be harnessed to fight cancer. To do this, T cells are collected from the patient’s blood and modified in the lab to allow them to recognize and attack specific tumor cells. They are then expanded and infused back into the patient, where they act as a “living medicine.”

 

CAR-T cells—from the lab to clinical practice

Fraunhofer partners with industry and universities

Kymriah® was the first CAR T-cell therapy to be approved in the United States, in 2017. During its clinical development in Europe, Fraunhofer supported its industry partner by developing manufacturing, quality control and logistics processes. The therapy received EU marketing authorization in 2018. Today, Fraunhofer supports companies and university hospitals in developing new cell and gene therapies, optimizing their processes and translating them into clinical practice. 

 

Using automation to accelerate CAR-T cell production

Application directly on site in hospitals

CAR-T cell production is time-consuming and expensive. In the EASYGEN project, Fraunhofer and its partners are developing an automated platform that will enable therapy production at hospitals within 24 hours. Manual processing is streamlined with automated workflows, improving cost efficiency and supply reliability.

 

Automation for CAR-T cell therapy

Artificial intelligence and highly automated manufacturing processes could make CAR-T cell therapies faster to produce, more standardized and ultimately more cost-effective. Fraunhofer is working with partners to develop innovative production platforms and explore how they could be adapted for use in other fields.

 

Interview with Michael Hudecek

Treatment can still cost up to 400,000 euros, but improved manufacturing methods are bringing costs down. A pioneer in cellular immunotherapy explains the new possibilities.

Solid CAR-T: modular mini-factories for automated CAR-T cell production

In the SolidCAR-T project, Fraunhofer and its partners have developed a modular mini-factory designed for automated, standardized CAR-T cell production directly at university hospitals. The team tested the concept using bile duct cancer as a model, with the goal of making personalized cell therapies available faster, at lower cost and of high quality.

Fraunhofer’s contribution to clinical implementation

Clinical trials: the path to approval

At Fraunhofer ITEM, new active ingredients and therapeutic approaches are studied in human participants under controlled conditions. Researchers systematically assess their safety and tolerability and look for early evidence of efficacy.

Cell therapy successfully treats severe rheumatoid arthritis

Immunotherapies such as CAR-T cell therapy are used primarily to treat cancer. In the future, custom-made CAR-T cell products could also be used to treat certain severe autoimmune diseases. In one study, researchers at the Fraunhofer Institute for Translational Medicine and Pharmacology ITMP were responsible for the technical analysis of samples.

More precise monitoring of cancer treatments

Cancer patients need regular follow-up exams, often to assess how well they are responding to a new treatment. The Fraunhofer Institute for Digital Medicine MEVIS is developing an AI-powered method to make these assessments faster and more accurate. 

Human-centered assistive technologies for interventional radiology

Working with partners, Fraunhofer IMTE is developing a robotic assistance platform for minimally invasive liver procedures. AI, robotics and ultrasound are designed to support medical professionals, to make procedures more precise and to reduce radiation exposure.

 

Fraunhofer Group for Health

The Fraunhofer Group for Health brings together expertise and technologies from six institutes across four key areas: drugs, diagnostics, devices and data. This interdisciplinary approach enables faster, more affordable innovation in health research.