Northwest Biotherapeutics (NW Bio), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, has received the regulatory approvals necessary to expand manufacturing and distribution of DCVax across Europe. These approvals will enable DCVax-L to be produced in Germany and supplied across borders to the UK for clinical trials evaluating the drug for the treatment of brain cancer. The approval for cross-border supply and distribution provides the flexibility to utilize manufacturing capacity in either the UK or Germany as needed to serve all of Europe.
These approvals will enable DCVax-L to be produced in Germany for the Phase III trial as well as Hospital Exemption cases under Section 4b of the German Drug law. The company and its partner, Fraunhofer IZI, have received the manufacturing authorization for the Phase III trial as part of the process of technology transfer, regulatory applications, regulatory review and inspections.
"Biotech companies, and especially cell therapy companies, have a tendency to grossly underestimate what it takes to build robust manufacturing and distribution networks," said Linda F. Powers, chief executive officer of NW Bio. "It requires intensive work years ahead of time, which does not receive much fanfare or credit, but can make or break the success of a Phase III trial program and commercialization. At NW Bio, we have been working intensively for years on building strong manufacturing and distribution arrangements in both the U.S. and Europe, and we are continuing to do so. It is now a major area of competitive differentiation and strength for us."