Research group  leaders at the BBZ:  Dr. Ronny Schulz  

Research group
leaders at the BBZ:
Dr. Ronny Schulz

GLP-ATMP, Maus, Schaf, Potency mit IZI

The working group, in close cooperation with the GLP-Unit of the Fraunhofer Institute for Cell Therapy and Immunology IZI, developed two GLP-compliant ectopic mouse models in the immunodeficient NSG mouse strain to evaluate the potential biodistribution or rather migratory potential as well as tumorigenicity of Advanced Therapy Medicinal Products (ATMPs). These models had been approved by the German Regulatory Authorities.
Furthermore, two large animal proof-of-concept studies  were performed under GLP-like conditions which are not in conformity with the pharmaceutical standards. However, the German Regulatory Authorities considered these proof-of-concept studies as to be tolerable in view of the controlled setting.


last update: 16.10.2017 

Contact

Dr. Ronny M. Schulz
Dipl. Ing. (FH), cand. MSc
Universität Leipzig
Centre for Biotechnology and Biomedicine
Deutscher Platz 5
04103 Leipzig

Phone: +49 341 97-31352
Fax: +49 341 97-31359
E-Mail

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