Supported by Northwest Biotherapeutics and Cognate BioServices Inc., the Fraunhofer Institute for Cell Therapy and Immunology received the manufacturing authorization according §13 German Drug Act (AMG) to produce Northwest Biotherapeutic´s DCVax®-L Brain, an autologous cell-based therapeutics for treatment of glioblastoma multiforme. This authorization is a key component for an upcoming clinical trial in Germany. The authorization was provided after a successful Good Manufacturing Practices (GMP) inspection by Landesdirektion Sachsen, in consultation with the higher federal authority Paul-Ehrlich-Institut. The authorization covers complete DCVax®-L Brain manufacturing for clinical trials. Under this authorization, Fraunhofer IZI will be able to manufacture DCVax®-L Brain in Germany and supply the DCVax®-L Brain product for clinical trials both in Germany and throughout the European Union.

The issuance of this manufacturing authorization is the culmination of nearly 18 months of technology transfer and regulatory processes, in which Fraunhofer IZI worked closely with Northwest Biotherapeutics and Cognate BioServices. A processspecific GMP inspection and subsequent granting of a manufacturing authorization is a prerequisite for the manufacture of an advanced therapy medicinal product (ATMP) intended for human administration in Europe. Cell therapies, including immune cell therapies such as DCVax®-L Brain, are classified as ATMPs. The process for manufacturing authorization is governed by European Directives, German Drug Act (AMG) and German Decree for the Manufacture of Medicinal Products and Active Pharmaceutical (AMWHV). The process includes checking whether all the stages of manufacture and quality controls are carried out in accordance with the basic principles of GMP. Such inspections assure that the facilities, equipment, personnel involved in production as well as the product ingredients and the process validation are suitable. A manufacturing authorization is only provided once a regulator is assured that manufacture and testing are carried out according to the latest standards prevailing in science and technology.

Further contact

Dr. Gerno Schmiedeknecht
Phone +49 341 35536-9705
gerno.schmiedeknecht@izi.fraunhofer.de