Fraunhofer IZI recieved manufacuring authorization for tumor vaccine CVac™

28.10.2011

The Fraunhofer IZI recieved the manufacturing authorization according §13 German Drug Act (AMG) to produce Prima Biomed´s CVacTM. This authorization is a key component for the planed clinical trial in europe. The authorization was provided after a succesful Good Manufacturing Practices (GMP) inspection by Landesdirektion Leipzig, in consultation with the Paul-Ehrlich-Institut. The authorization covers complete CVacTM. manufacturing for testing in clinical trials.

GMP inspection and subsequent manufacturing authorization is a prerequisite to production of any medicinal product intented for human administration in Europe. The process is governed by European Directives and German Drug Act (AMG). 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 the process validation are suitable. Manufacturing authorization is only provided once a regulator is assured that manufacture and testing is carried out according to the latest standards prevailing in science and technology.