BETHESDA, Md., Dec. 4 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. (“NWBT” or the “Company”) announced today that the US Patent and Trademark Office has allowed its patent application on a system for automation of the initial stages of the manufacture of the Company’s DCVax(R) therapeutic cancer vaccines. These initial manufacturing stages are key to the very high concentration of dendritic cells (which are the critical ingredient) in the finished DCVax(R) vaccine.
The essential active component in the DCVax(R) vaccine is the patient’s own master immune cells, called “dendritic cells.” The dendritic cells are responsible for mobilizing the entire immune system, and its many players (including T cells, B cells and the antibodies they produce, natural killer cells and others). The dendritic cells are obtained through a blood draw from the patient, with the desired cells carefully separated from the many other types of cells in the patient’s blood. The more rigorously and precisely the dendritic cells are isolated, the higher the concentration of this active ingredient in the vaccine.
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(R).
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.
“We have spent over a decade working on manufacturing technologies to achieve cost efficiencies and scalability,” said Dr. Marnix Bosch, Chief Technology Officer of NWBT. “NWBT has already achieved significant cost efficiencies by pioneering a unique batch manufacturing process. These efficiencies will be further enhanced by the automated system we have developed, and it is very gratifying to receive the allowance of this important US patent on our automated device.”
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