GMP-Facility (Good Manufacturing Practice)
Good Manufacturing Practice (GMP) compiles guidelines required in order to ensure high standards and reproducibility for the production of drugs.
These guidelines provide minimum requirements that a pharmaceutical manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
GMP is a substantial prerequisite for a successful translation of basic research into clinical applications, like cellular therapies .
Welcome
The GMP cluster offers fully equipped cleanrooms for cell biology & material sciences under aseptic conditions. Several cleanrooms (ISO-5, ISO-7 & ISO-8) are custom-designed for the isolation, cultivation & expansion of human cells as well as the production of biomaterials & scaffolds. This compliance with legal requirements is mandatory in order to use these products in clinical trials and finally to establish new therapies.
Specially trained and skilled technicians perform isolation, primary cell culture, quality controls and documentation in a GMP/FDA conform manner.
Experienced staff support the translation "from bench to bedside" and advise users in medico-legal topics.