Department of GMP Cell and Gene Therapy

The Department of GMP Cell and Gene Therapy operates Fraunhofer IZI's two modern GMP facilities consisting of six separate clean room suites (altogether 13 clean room grade B manufacturing rooms) which have been specially optimized for manufacturing of cell and gene therapy products, so called Advanced Therapy Medicinal Products – ATMP. The particular specialty of the about 110 highly qualified staff members is the GMP-compliant manufacturing and quality control of investigational medicinal products.

GMP-compliant process and quality control development as well as the creation of Standard Operating Procedures (SOPs) are intensively discussed with the project partner before being implemented. The leading staff in charge has many years of experience in designing GMP-processes in the cell therapy area.


To date, more than 3500 autologous and allogeneic cell products have been released for clinical use since 2006, including 500 different autologous CAR-T cell products.



Here we show you a selection of current and finished projects.


Find out here about devices and systems that we use for our work.


Here you will find an overview of all publications that have emerged from the research work of our working group.


GMP certificate

From the press

April 17, 2023 | News

Preclinical and clinical development of a novel CAR-T cell therapy for the treatment of multiple myeloma and clear cell renal cell carcinoma


December 14, 2022 | News

Fraunhofer IZI implements digital Manufacturing Execution System

October 7, 2019 | Media information | Novartis

One year on: Kymriah® CAR-T cell therapy in Germany


August 31, 2018 | Press releases

Fraunhofer IZI and Novartis continue successful collaboration with CAR-T cell therapy