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 medicinal products (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 disposes of a very modern for small animal facility, as well as a external large animal facility (Oberholz, University Leipzig) and a surgery for small and large animals. 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