Cell Engineering / GMP
Fraunhofer Institute for Cell Therapy and Immunology IZI
- © Fraunhofer IZI
The Cell Engineering / GMP Unit operates Fraunhofer IZI‘s two modern GMP facilities consisting of separate clean room suites which have been specially optimized for manufacturing cell-based medicinal products (Advanced Therapy Medicinal Products – ATMP). The particular specialty of the 40 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.