Department of GMP Cell and Gene Therapy

The Department of GMP Cell and Gene Therapy operates Fraunhofer IZI's two modern GMP facilities consisting of six separate clean room suites (altogether 13 clean room grade B manufacturing rooms) which have been specially optimized for manufacturing of cell and gene therapy products, so called Advanced Therapy Medicinal Products – ATMP. The particular specialty of the about 105 highly qualified staff members is the GMP-compliant manufacturing and quality control of investigational medicinal products.

GMP-compliant process and quality control development as well as the creation of Standard Operating Procedures (SOPs) are intensively discussed with the project partner before being implemented. The leading staff in charge has many years of experience in designing GMP-processes in the cell therapy area.