Department of Cell and Gene Therapy Development

The Department of Cell and Gene Therapy Development researches and develops cell and gene therapy technologies and realizes the transfer of manufacturing processes from an experimental stage to GMP-compliant procedures.

The focus is on antigen-specific T cells, CAR T cells, CAR NK cells, dendritic cells, mesenchymal stromal cells and tissue engineering products.

The department's competencies, which build on each other, include research and development, preclinical evaluation and GMP process development for cell and gene therapies up to transfer into pharmaceutical manufacturing processes. Manufacturing parameters and quality controls can be tested and optimized flexibly and cost-efficiently.

New technologies (including digitalization, artificial intelligence, automation) as well as clinically relevant application aspects are considered at all stages of development.

In addition, biomolecules such as antibodies, proteins, enzymes and, in the future, viral vectors are produced in pharmaceutical quality in a separate GMP manufacturing unit.

After successful process optimization, investigational medicinal products can be produced by the Department of GMP Cell and Gene Therapy and further accompanied until approval.

Cell and Molecular Biology NK Cell Technologies In Vivo Models GMP Development GMP Biopharmaceuticals

Cell and Molecular Biology

The Cell and Molecular Biology Unit researches and develops ways of manufacturing and testing the functionality of cellular immunotherapies. Besides viral and non-viral / mRNA-based gene transfer for cell modification, antibody-incubated cell therapies are also designed for graft optimization. In order to carry out functional testing with cell and gene therapeutics, the group creates human test systems based on standardized and patient-specific cell culture models.


NK Cell Technologies

In recent years, gene-modified T cells have led to astonishing results in the treatment of some types of leukemia. However, these therapies are costly, require long manufacturing processes and are only effective against a few tumor types.

In the NK Cell Technologies Unit, state-of-the-art genetic engineering techniques are used to enable natural killer (NK) cells to efficiently fight cancer cells. NK cells are part of the innate immune system, and NK cell-based advanced therapy medicinal products (ATMPs) can be produced from healthy donor cells, creating an "off-the-shelf" product that can be delivered to many patients. Current therapeutic approaches using NK cells, while very safe for patients, are often not effective enough to permanently reduce tumor burden. The focus of our work is on various approaches to increase the cytotoxicity of NK cells against tumor cells.


In Vivo Models

The In Vivo Models Unit investigates active agents as well as cell and gene therapeutics with the aim of elucidating clinically relevant immunological issues in the living organism. One of the unit’s main areas of competence involves establishing and validating new preclinical animal models, especially in the field of hematology and immuno-oncology.


GMP Development

The GMP Development Unit converts highly manual academic laboratory procedures into GMP-compliant manufacturing processes to obtain official manufacturing authorization for the production of clinical trial samples, including (semi-)automated equipment and solutions.

We also have extensive knowledge and experience in the establishment and optimization of new analytical methods (e.g. cytotoxicity or efficacy assays) and the documentation and evaluation of all manufacturing- and quality-related data under GMP-like conditions.


GMP Biopharmaceuticals

In recent years, the increasing number of therapeutic monoclonal antibody (mAb) candidates under preclinical and clinical development have required new flexible, efficient, and economic opportunities for GMP production of therapeutic antibody candidates.

Publications of the department


Here we show you a selection of current projects.



Fraunhofer lighthouse project

Automated production technologies for mRNA-based drugs


QualiBioPharma – Qualification of specialists in biotechnology

News / 6.9.2022

Roadmap for future production of sufficient product numbers of cell-based cancer drugs

Researchers from the Fraunhofer Institute for Cell Therapy and Immunology now summarize the current state of research and discuss possible solutions to overcome biological and technical hurdles in their recent article "Potential solutions for manufacture of CAR T cells in cancer immunotherapy" published in the journal Nature Communications.

Newsflash / 21.5.2021

Simplified method developed for monitoring CAR T-cell therapies using flow cytometry

Researchers at the University of Leipzig, in cooperation with the Fraunhofer Institute for Cell Therapy and Immunology IZI and Beckman Coulter Life Sciences GmbH, have established a flow cytometry method that simplifies the analysis of CAR-T cells from patients' blood.

Press information / 1.2.2021

Optimization of novel immune cell therapies

The GMP Process Development Department collaborates with Klinikum Chemnitz gGmbH (Chemnitz hospital). Department head PD Dr. Stephan Fricke, as specialist in internal medicine, hematology and oncology and as senior physician at the Clinic for Internal Medicine III at Chemnitz hospital, builds the bridge to application.

employees working on a bench in clean room and laboratory
© Fraunhofer IZI