Announcements
10/25/2011
Manufacturing Authorisation Granted in Germany
Australian health care company Prima BioMed Ltd (ASX: PRR) (Prima) is pleased to announce that Prima’s manufacturing partner for Europe, the Fraunhofer Institute for Cell Therapy and Immunology IZI, has received manufacturing authorization according §13 German Drug Act (AMG) to produce CVac™. This authorization is a key component of Prima’s regulatory application to commence the planned CANVAS trial in Europe.
The authorization was provided after a successful Good Manufacturing Practices (GMP) inspection by Landesdirektion Leipzig, in consultation with the Paul-Ehrlich-Institut. The authorisation covers the complete CVac™ manufacturing for testing in clinical trials.
Article as pdf >> |