GLP Test Facility

© Fraunhofer IZI

The Department of Therapy 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

 

Further test facilities:

 

Statement of GLP Compliance

Studies

Publications