Fraunhofer IZI receives Statement of GLP Compliance for immunotoxicologic testing

19.11.2009

The Fraunhofer Institute for Cell Therapy and Immunology IZI officially has received the Statement of GLP (Good Laboratory Practice) Compliance for the Area of Expertise 9 with the specification "Immunotoxicologic testing in vitro". The successful initial inspection by the Saxon State Ministry of the Environment and Agriculture as responsible regulatory authority took place in August.

Now, the Fraunhofer IZI is able to implement current requirements of the European Medicines Agency (EMEA) for R&D services for developers of new pharmaceuticals. Those specific regulations are presented in directive S8 "Immunotoxicity studies for human pharmaceuticals" stated by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

Dr. Jörg Lehmann, director of the GLP facility and Vice Head of Department Cell Engineering at the Fraunhofer IZI mentions that this represents only the first step. In spring 2010 an extension of the GLP Compliance for "Immunotoxicology in vivo" will be applied for, including in particular testing on immunogenicity, tumorgenicity and biodistribution in preclinical evaluation of cell therapeutics and biopharmaceutics. A pilot study in a large animal model (sheep) concerning cell therapy of focal cartilage damage using autologous mesenchymal stem cells cultured in vitro is already in progress.