Institute for Transfusion Medicine and Gene Therapy

Unit Leader: Dr. Tatjana Cornu

Good Manufacturing Practice (GMP) is a quality management system for ensuring that products are consistently manufactured and controlled according to high quality standards. It is designed to minimize the risks involved in the production of cell therapies that cannot be eliminated through testing of the final product.

The GMP Development Unit adapts the various stages of production of Advanced Therapy Medicinal Products (ATMPs), which are developed in the research department, to GMP-compliant conditions in adequate clean rooms. Additional control and validation steps will be implemented to safeguard proper characterization of the final product, including its quality, safety and efficacy (Guidelines EMA/CAT/GTWP/671639/2008) and the fulfillment of all conditions for approval of production by the federal and state authorities (§13 and §20b AMG, regulation (EC) no. 1394/2007 on ATMPs).