The GLP (Good Laboratory Practice) is a quality assurance system that sets out the regulatory framework conditions for the non-clinical and preclinical testing of chemicals and drugs. It falls under the Chemicals Act in the Federal Republic of Germany.

Fraunhofer IZI in Leipzig has been certified as a GLP test facility since 2009. It specializes in testing advanced therapy medicinal products (ATMPs) besides conducting immunotoxicological tests. With regard to the safety testing of ATMPs in particular, the Fraunhofer IZI’s GLP test facility has set an example also in terms of concepts over the past few years. The individual planning and implementation of GLP tests in line with the latest state of scientific and technical knowledge forms part of the portfolio offered by the test facility. This also involves developing and validating suitable in-vitro and in-vivo models. Alongside state-of-the-art laboratory spaces, the test facility also boasts optimal conditions for keeping laboratory animals and for performing surgical procedures on small and large animals.

The addition of the Halle (Saale) test site signals another expansion of the range of methods and assays conducted in line with GLP. The focus of GLP testing here lies on analyzing so-called low-molecular drugs (small molecules) using liquid chromatography–mass spectrometry (LC-MS). The two sites therefore complement each other well in terms of methods and subject areas and are able to offer an extremely comprehensive portfolio of tests from a single source.

The test facility is currently certified for testing category 9: "safety tests – immunotoxicity/immunogenicity", with plans in place to cover further testing categories in the near future.

Contact

Dr. Jörg Lehmann
Head of GLP test facility
Department Therapy Validation

Dr. Mirko Buchholz
Head of test facility Halle (Saale)
Department of Drug Design and Target Validation