The Translational Cell Therapy off-site unit develops and validates cell-based advanced therapy medicinal products (ATMPs). To do this, it conducts translational research and develops GMP-compliant manufacturing protocols for cell therapeutics at the interface to preclinical development right through to their transfer into clinical trials. Cell and genetic engineering methods and strategies are implemented and optimized here to specifically manufacture killer lymphocytes and their subpopulations. The ability to overcome so-called tumor immune escape mechanisms in cancer cells is key here. This is achieved by using activated and genetically modified effector cells together with checkpoint inhibitors and stimulating immune cells. These cell therapies boost immune surveillance and strengthen the elimination of resistant cancer cells as well as their malignant precursor cells (so-called tumor stem cells). Another focus of development lies in optimizing the transduction capacity of effector cells using chimeric antigen receptors (CARs) in order to increase cytotoxicity to malignant cells. To do this, human effector cells are separated following lymphapheresis by means of GMP-suitable, fully automated, closed-system production, genetically modified as necessary and expanded as part of clinical upscaling. Moreover, the group is developing GMP-compliant manufacturing and expansion protocols in order to proliferate a sufficient number of activated effector cells.
© Fraunhofer IZI
GMP-compliant cell separation
CliniMACS Plus, Miltenyi Biotec (separation)