Fraunhofer Institute for Cell Therapy and Immunology IZIGMP Cell and Gene Therapy
Dendritic cell based ATMP
From 2013 to 2015, Fraunhofer IZI manufactured investigational medicinal products of an autologous somatic cell therapy based on dendritic cells for the treatment of ovarian cancer for an Australian biotechnology company and its German subsidiary. In addition to the process transfer from Australia and the establishment of all quality controls, the qualification of the apheresis collection centers involved was also one of the institute's key tasks.
Autologous stem cell preparations from umbilical cord blood
From 2009 to 2013, Fraunhofer IZI supported an Italian-German biotechnology company in setting up a stem cell bank to store cryopreserved hematopoietic stem cell preparations from umbilical cord blood. After completing the necessary steps for establishment and process development, as well as validating the manufacturing process and analytical methods, the institute supported the GMP-compliant manufacturing and quality control of the stem cell preparations.
Autologous skin tissue grafts from hair root stem cells
From 2007 to 2013, Fraunhofer IZI supported a German biotech company in the manufacturing and quality control of an autologous tissue engineering product. Epidermal equivalents were produced in Fraunhofer IZI's clean rooms from outer hair root sheath cells, for use in treating chronic wounds. Additionally, a master and working cell bank for feeder cells required for skin graft production was manufactured and analyzed.
Dendritic cell based ATMP
From 2013 to 2015, Fraunhofer IZI produced investigational medicinal products, including placebos, for a Phase III clinical trial in Germany and the UK. The trial aimed to evaluate the efficacy of an autologous somatic cell therapy based on dendritic cells for treating glioblastoma. This work was carried out on behalf of a US biotechnology company and its German subsidiary.
CAR-T cells
On August 8, 2016, Fraunhofer IZI began manufacturing the first patient batch of CTL019 produced directly in Europe. The production of these investigational medicinal products contributed to the European approval of Kymriah® (tisagenlecleucel). This was a milestone in modern cancer therapy. To date, we have produced more than 600 CAR-T cell products and CAR-T intermediate products for various studies on behalf of different industrial and academic clients. We are proud to have played an integral role in this remarkable development, and we look forward to continuing to contribute to innovative cell and gene therapy projects by providing our unique European GMP expertise and infrastructure.
Cardiac-derived adherent proliferating cells
On behalf of the Charité university hospital Berlin, a manufacturing license in accordance with Section 13 of the German Medicines Act was obtained in 2018 for an autologous investigational medicinal product based on cardiac-derived adherent proliferating cells (CardAPcells) for the treatment of chronic heart failure. The project involved the transfer of an experimental process from the project partner's research laboratory to a GMP environment. This included creating the necessary GMP-compliant documentation, establishing a GMP-compliant manufacturing process with all necessary quality controls, and validating the manufacturing process and safety-related analytical methods.
Implantable medical device
Between 2017 and 2021, as part of a cooperation project with a German-Australian medical device company, Fraunhofer IZI established and tested a process developed by the project partner for manufacturing breast reconstruction implants. These implants were made from a biodegradable polymer using a special 3D printing process. As the implants were intended for implantation, production was carried out under the Fraunhofer IZI quality assurance system in a defined clean room environment. The implants produced in this way were initially used for testing and validation purposes, as well as for a GLP-compliant long-term study to evaluate clinical safety.
Allogeneic cell therapy product
Since 2025, Fraunhofer IZI has been providing investigational medicinal products for an allogeneic somatic cell therapy for the treatment of focal cartilage defects in the knee on behalf of a German biotechnology start-up company. The institute is responsible for aseptic filling, release testing and certification by the qualified person. The investigational medicinal product is based on mesenchymal stem cells derived from umbilical cord tissue and is intended to support regenerative processes to restore hyaline cartilage.
CAR-T cells for the treatment of solid tumors
Since 2025, one of our current projects has involved manufacturing investigational medicinal products for a Phase I clinical trial, which is evaluating the safety and tolerability of autologous ROR1-CAR-T cells in ROR1+ tumors, including solid tumors. In cooperation with the University Hospital of Würzburg, Fraunhofer IZI has already carried out GMP process development and preclinical efficacy and safety evaluations under GLP.
Allogeneic feeder cells / tumor-infiltrating lymphocytes
Since 2018, we have supported a U.S.-based company in the development of an adoptive cell therapy based on tumor-infiltrating lymphocytes (TILs) for the treatment of solid tumors. Following the successful transfer and validation of the manufacturing process and analytical methods, we now supply allogeneic feeder cells used in the production of TILs.