Department of Cell and Gene Therapy Development

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.

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.

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.

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.

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.