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news.German-based Fraunhofer IZI has gained approval and certification from the regional and national regulatory agencies in Germany to manufacture its partner's, Northwest Bio, DCVax-L immune therapy, designed for use in patients with Glioblastoma multiforme brain cancer.
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The certification enables Fraunhofer IZI to manufacture as well as supply the DCVax-L product for clinical trials in Germany and throughout the European Union.
Fraunhofer said receiving manufacturing certification for DCVax-L is the culmination of a nearly 18-month process involving close collaboration with its contract manufacturer, Cognate BioServices.
Fraunhofer IZI GMP cell engineering department head Gerno Schmiedeknecht said obtaining the certification for DCVax-L will enable the company to proceed with production for clinical trials to bring the much-needed, important new technology to patients.
Northwest Bio CEO Linda Powers said the German regulatory process for manufacturing certification is rigorous and detailed, with far more extensive requirements than some other European countries.
"It is a testament to the expertise and professionalism of our partners, Fraunhofer IZI and Cognate BioServices, that DCVax-L has now received this manufacturing certification," Powers added.