BETHESDA, Md., July 25, 2012 /PRNewswire/ -- Northwest Biotherapeutics, Inc. (OTC.BB: NWBO) (the "Company" or "Northwest Bio") announced today that its partner in Germany, Fraunhofer IZI, has received the official approval and certification from the regional and national regulatory agencies in Germany (including the Paul-Ehrlich-Institut, or PEI – the German equivalent of the U.S. FDA) for the manufacture of Northwest Bio's DCVax®-L immune therapy for human patients with Glioblastoma multiforme brain cancer.
Cell therapies, including immune cell therapies such as DCVax®-L, are classified as "Advanced Therapy Medicinal Products" (ATMPs) in the European Union (E.U.). Manufacturing of ATMPs for treatment of human patients must comply with E.U. Directives, the German Drug Act (AMG) and the German Decree for the Manufacture of Medicinal Products and Active Pharmaceuticals (AMWHV).
Fulfilling these legal requirements, and obtaining manufacturing certification under Section13 of the German Drug Act (AMG), are key requirements and steps for clinical trials in Germany. Furthermore, with this certification, Fraunhofer IZI will be able to manufacture DCVax®-L in Germany and supply the DCVax®-L product for clinical trials both in Germany and throughout the European Union.Obtaining this manufacturing certification for DCVax®-L is the culmination of a nearly 18-month process involving close collaboration among Fraunhofer IZI, the Company, and its contract manufacturer, Cognate BioServices. The process began with a 4-month period of intensive technology transfer, training in facilities in both Germany and the U.S., establishment and validation of specialized supply arrangements, shipping and distribution arrangements, and related matters. This was followed by the manufacturing application to the German regulators, and the 14-month regulatory process, with a final inspection by the state and national level German regulators on June 12-13, 2012. The results of that inspection were favorable: there were no adverse "findings," and only limited follow-up work requested by the regulators. Fraunhofer completed and submitted the follow-up work within weeks, and the final regulatory certification was received rapidly thereafter. "We are very pleased to reach this important milestone in our joint program with Northwest Bio," commented Dr. Gerno Schmiedeknecht, head of the Department Cell Engineering GMP for Fraunhofer IZI. "Manufacturing aspects are particularly important for sophisticated Advanced Therapy Medicinal Products such as DCVax®-L. Obtaining this certification for DCVax®-L will enable us to proceed with production for clinical trials to bring this much-needed, important new technology to patients."