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news.US-based Northwest Biotherapeutics (NW Bio) and its partners have obtained the necessary regulatory and institutional approvals in both Germany and the UK to expand the scope of the manufacturing in Germany of the company's DCVax-L product for brain cancer.
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The approvals will enable DCVax-L to be produced in Germany and supplied across borders to the UK for the clinical trials.
The latest approvals for cross-border supply of DCVax-L is in addition to the manufacturing capacity in the UK already developed by NW Bio with its partner, Kings College London.
DCVax-L can now be produced in Germany not only for the Phase III clinical trial, but also for Hospital Exemption cases under Section 4b of the German Drug law.
Separate regulatory applications and authorizations are required, at both the Federal and local levels, for the manufacture of products for Hospital Exemption (Section 4b) versus for clinical trials.
NW Bio and its partner Fraunhofer IZI already received the manufacturing authorization for the Phase III clinical trial last summer, as the culmination of a 1-1/2 year process of technology transfer, regulatory applications, regulatory review and inspections.
NW Bio CEO Linda Powers said that the cell therapy companies and Biotech companies has a tendency to grossly underestimate the robust manufacturing and distribution networks.
"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," Powers added.