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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
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