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Northwest Biotherapeutics Receives Approval of US Patent for Cost Saving Automation of High-Concentration DCVax(R) Manufacturing
Date:12/4/2009

te similarities among the cells and despite size differences of as little as a few microns. (By comparison, a human hair is around 50 microns in size.)

Use of NWBT's automated system has already been cleared by FDA for human clinical trials. The INDs (Investigational New Drug applications) which have been cleared by the FDA for five different cancers include use of the automated system in the manufacturing process for DCVax®.

Such automation of the initial stages of manufacturing DCVax® will greatly reduce the costs involved, including a more than 10-fold reduction in labor costs. For example, under current (first generation) processes, it takes 24 man hours to complete the initial manufacturing stage for 6 patients' vaccines. With the automated device, it takes only 2 man hours to complete the same work for 6 patients' vaccines. In addition, the need for certain high-cost materials is eliminated.

In addition to major reduction of direct costs, the automation also offers significant reduction of indirect costs: the reduction of capital costs for manufacturing facilities. Each manufacturing step that is "open" (i.e., in which the cells have any exposure to the air) must be carried out in "cGMP" clean room facilities where the air is sterile in the whole manufacturing suite. Such facilities are extremely costly to build, operate and maintain - so costly that the recoupment forms a large part of the costs of the vaccine. Automation can turn an "open" manufacturing step into a "closed" step, in which the cells remain enclosed in a machine or container, and have no exposure to the air. That eliminates the need for the air to be sterile, and enables those automated steps to be conducted in low-cost, ordinary space and facilities.

The automated system developed by NWBT, on which the US patent has now been allowed, makes just such a change: it turns the initial stages of DCVax® manufacturing into "closed
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SOURCE Northwest Biotherapeutics, Inc.
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