NW Bio paves way for large-scale expansion of product manufacturing, handling and distribution

Published: 29-Jan-2014

Signs multiple agreements with Cognate Bioservices for upgrade of DCVax


Northwest Biotherapeutics (NW Bio) has agreed with Cognate Bioservices to begin large-scale expansion of the manufacturing, storage, handling and distribution of its DCVax personalised immune therapies for solid tumour cancers.

The agreements with Cognate, located in Hanover, MD in the US, allow NW Bio to begin a scale-up programme for expanding its clinical programmes in the US and Europe, and for any 'compassionate use programmes or other early access or expanded access programmes which the company might undertake'.

They also allow for long-term preparations for potential commercialisation and product validation.

NW Bio, based in Bethesda, MD says cell therapy products, such as personalised immune cell therapies for cancer, are especially challenging and complex and the regulatory requirements are 'far more rigorous for Phase III clinical trials than for Phase II trials'. Systems for managing such cell therapy products for thousands or tens of thousands of patients are also extremely demanding.

'We are excited to enter into a broad programme to expand capacity and build large-scale infrastructure, systems and operations under these agreements with Cognate,' said Les Goldman, Senior VP of Business Development at NW Bio. 'Such a programme is essential for our future success, and involves a major commitment of resources and time.'

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