This area will supply important technological platforms for the above areas and will be essential for translation of initial clinical trials into broad clinical application.

To follow the effects of recombinant agents and modified cells or tissues in vivo, we will further strengthen our investments in bioimaging and cell marking (genetic and phenotypic), and study the long-term integrity of engineered and clonally expanded cell populations in the homeostatic, stressed and ageing organism (interaction with Areas A & B).

1. Imaging and vigilance

To follow the fate of recombinant agents and modified cells or tissues in vivo, we will strengthen our investments in bioimaging and cell marking, and study the long-term (epi)genetic and phenotypic integrity of engineered and clonally expanded cell populations in the homeostatic, stressed and ageing organism.

2. Process development and clinical trials

Our translational activities include a unique, integrated concept towards “GXP”: good practice for labo-ratory, manufacturing and clinical work (GLP->GMP->GCP). An integrated component of these activities in process development is a unit that focuses on upscaling technologies. Clinical applications will be supervised to guarantee highest quality in preclinical data collection, product design, biocompatibility testing and the conception, conduct and data management of clinical trials. 

Including integrated concept for “GXP”

Included in this global assessment are the derivation, expansion, manipulation, and characterization of human stem cell lines, as well as preclinical efficacy and toxicity testing in appropriate animal models. Large-scale cell expansion and biocompatibility testing are further important translational topics. Potential toxicity will be primarily addressed by investigating genetic and epigenetic instability and inappropriate differentiation. Our translational activities include an integrated concept for “GXP”: good practice for laboratory, manufacturing and clinical work (GLP->GMP->GCP). Clinical projects are supervised to guarantee highest quality already in preclinical data collec- tion, product design, biocompatibility testing and finally the conception, conduct and data management of clinical trials. 

Area C will supply important technological platforms for Areas A and B and will be essential for translation of developments from Area B into clinical application. 

Area Manager

B. Schlegelberger, Hannover Medical School, Institute of Cell and Molecular Pathology

H. Drexler, Hannover Medical School, Department of Cardiology and Angiology