DCVax® milestones reached

20.4.2012

Significant milestones have been reached in the ongoing collaboration between Fraunhofer IZI and Northwest Biotherapeutics (NW Bio) and its contract manufacturer, Cognate BioServices (Cognate).

A four-month long technology transfer of the complex manufacturing process for the autologous cell therapeutic DCVax®-L Drug (Brain) from the USA to Leipzig was successfully completed in close cooperation with project partners Cognate and NW Bio. The extensive documentation required to apply for manufacturing authorisation in accordance with Section 13 of the German Drug Act (AMG) has been submitted to the responsible pharmaceutical supervisory authority, and the nine-month long regulatory process (following the technology transfer process between the parties) has been completed up to the point of the official acceptance inspection. That inspection is the final step which has to be carried out before the manufacturing authorisation can be granted, and is scheduled for June 2012. The completion of the processes to date represent significant milestones toward the conduct of the clinical trial using DCVax-L for brain cancer in Germany.