NWBO News Fraunhofer IZI Receives Official Certifi
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NWBO News Fraunhofer IZI Receives Official Certification For Manufacturing Of Northwest Bio's DCVax®-L Product
2012-07-25 08:30 ET - News Release
Culmination of Nearly 18-Month Process, In Close Collaboration With Northwest Bio and Cognate BioServices
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.
(Logo: http://photos.prnewswire.com/prnh/20110329/SF73084LOGO )
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.
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