Fraunhofer Institute for Cell Therapy and Immunology IZI
GLP Test Facility
The Department of Preclinical Development and Validation enables the design and performance of preclinical efficacy and safety studies for novel drug candidates (especially Advanced Therapy Medicinal Products, ATMPs) and medical devices (ISO 10993) under GLP or GLP-analogous conditions. This includes the development and validation of suitable in vitro and in vivo models. The test facility boasts a state-of-the-art setup for keeping small animals as well as small animal operating rooms. Furthermore, a broad range of validated SOPs for devices and methods has been implemented.
GLP-certified since 2009:
Testing Category 9: Safety tests for ATMPs – immunotoxicity / immunogenicity in-vitro / in-vivo
(see also: http://www.bfr.bund.de/cm/349/good-laboratory-practice-GLP-test-facilities-in-the-monitoring-programme-germany.pdf)
GLP-certified since 2023:
Testing Category 2: Toxicity studies
Further test facilities:
- Fraunhofer IZI – Department of Drug Design and Target Validation, Halle (Saale)
- Oberholz – Faculty of Veterinary Medicine at Leipzig University