BETHESDA, Md., Sept. 10, 2013 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax ® personalized immune therapies for solid tumor cancers, announced today that it has been issued another key U.S. patent (#8,518,636) covering a next generation process for manufacturing lower cost human dendritic cells of both a higher quality and higher reliability.
This next generation system has already been cleared by FDA for use in the manufacturing for NW Bio's clinical trials. These systems are now in use producing the vaccines which already have been injected into the tumors of DCVax-Direct patients.
This next generation process automates certain crucial stages of the manufacturing process within a self-contained system. Automating some or all of the production process within such a system can eliminate the need for today's extremely expensive "GMP" clean rooms (with, for example, special air handling to maintain sterile air in an entire building). Eliminating the special costs for such clean rooms will further enhance product economics, allowing wider margins and pricing flexibility.At the heart of this next generation manufacturing advance are Tangential Flow Filtration machines, or TFF for short. These machines and associated disposable sets provide an automated, closed system for the crucial stages of the manufacturing process isolating the particular immune cells that become the dendritic cells in the Company's DCVax products. Most significantly, the dendritic cells produced through this next generation system, are manufactured using procedures which are more closely related to what one finds in nature. The result is increased potency of the dendritic cells (which are the active agent in the DCVax products). As such, full implementation of the TFF can be another major step forward in advancing immune therapies, and help to position the manufacturing of DCVax products for potential commercial scale-up when the time comes.