US biotech firm Northwest Biotherapeutics (Nasdaq: NWBO) has entered into a set of agreements for large-scale expansion of the manufacturing, storage, handling and distribution of its DCVax-L and DCVax-Direct products, with the company's long-time contract manufacturer, Cognate Bioservices.
Northwest Bio previously announced plans for these agreements, and the program and capacity expansions that they will provide, in July, 2013, and during the remainder of 2013. The agreements were entered into on January 17, 2014.
In aggregate, these agreements provide for a comprehensive scale-up program for expansion of the company's clinical programs in both the USA and Europe, and for any compassionate use programs or other early access or expanded access programs which the company might undertake. These agreements also provide for an extensive development program to carry out long-term preparations for eventual potential commercialization (including building the infrastructure, systems and logistics that will be needed), and to undertake the extensive product validations that will be required for a product to be considered for regulatory approval.
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