GMP is a substantial prerequisite for a successful translation of basic research into clinical applications, like cellular therapies.

The core facility's aim is to provide internal and external users a broad range of services based on its long-standing and diverse expertise in the development, manufacture and therapeutic use of advanced-therapy medicinal products (ATMP) and tissue engineering products (TEP) and their regulatory drug approval.

The core facility "Good Manufacturing Practice Biomedical Campus Dresden“ (GMPBD) consists of 5 GMP units which are mainly located on the university hospital campus. Part of this GMP cluster are cleanrooms at the Medical Clinics I (hematopoietic stem cells / cell therapy products) and the Medical Clinics III (islet transplantation program), at the Center for Regenerative Therapies (stem cell therapies), the Max Bergmann Centre of Biomaterials and the German Red Cross (blood / blood products). The GMP core offers a unique infrastructure for applied biomedical research: GMP-conform production sites with state-of-the-art equipment as well as medico-legal competence.

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 experienced technicians perform isolation, primary cell culture, quality controls and documentation in a GMP/FDA conform manner. Practiced staff support the translation from bench to bedside and advise users in medico-legal topics.

Due to the long lasting, sound expertise we were already able to implement standard operating procedures (SOPs) for the generation of GMP-grade Mesenchymal Stromal Cells (MSC), virus-specific T-lymphocytes and islet cells.

Implemented protocols and cell types

Good to know in addition:

Due to regulatory requirements no genetically modified cells can be processed in our facility.