Fraunhofer Institute for Cell Therapy and Immunology IZIFraunhofer IZI receives GMP-manufacturing authorisation for autologous stem cells derived from bone marrow
After a successful inspection by the competent authority a GMP-manufacturing authorisation according to article 13 German Drug Act for manufacturing and quality control of autologous stem cells derived from bone marrow was granted to the GMP-facility of the Fraunhofer Institute for Cell Therapy and Immunology IZI.
The manufacturing authorisation covers the manufacturing of investigational medicinal products for upcoming clinical trials and includes permission according to article 20 b, sub paragraph 2 for the procurement and testing of tissues.
"We are glad that our efforts to guarantee highest quality requirements were confirmed by the authorizing officials", says Dr. Gerno Schmiedeknecht, Head of the GMP unit and Head of Department at the Fraunhofer IZI.