Replies to post #445493 on NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

senti, I missed those conversations, but it doesn’t surprise me that this has been discussed before, or that there were naysayers suggesting that it couldn’t be used for DCVax-L.

I don’t know if it was actually validated for DCVax-L, but the patent was announced close the the mid-point of enrollment of the DCVax-L trial. I think it was originally designed during the manufacturing development work for DCVax-Direct, and it was obviously used in the production of DCVax-Direct for that clinical trial, but it was FDA approved, and I have always assumed that it could also be used for DCVax-L, partly because NW Bio said it could be used in DCVax trials, and products.

Tangential flow filtration is a common method to isolate or separate cells. It uses pressure and counter flow to push the desired or undesired cells through ultrafiltration membranes with highly defined pores. The system that Northwest Bio has patented, is a self-contained, closed automated system that separates the desired monocytes (precursors to dendritic cells) from the undesired blood constituents like lymphocytes, erythrocytes, platelets etc., from the patient’s leukapheresis material. This is the first step in the manufacturing process for both DCVax-L and DCVax-Direct. The system has disposable sets where I assume the monocytes are collected so they can be transferred to the next process step. (culturing)

There are a number of commercially available automated cell processing systems that could be used for the cell separation step, (remember Flodesign Sonics?) but I’m assuming that Advent will use Northwest Bio’s patented technologies for the two most critical processes.

NW Bio's Patent Portfolio Further Expanded With Manufacturing Automation Patent

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.

"Ongoing development of our technologies for cost reduction and simultaneous enhancements in quality continues to strengthen our competitive position," commented Linda Powers, CEO of NW Bio. "The TFF system provides major advantages in this regard, and the issuance of this latest patent is a significant addition to our portfolio of over 180 issued and pending patents worldwide."
Dr. Marnix Bosch, one of the inventors on this line of patents, says: "We have approached the issues of dendritic cell manufacturing from a process-improvement perspective, and the material covered in these issued patents takes advantage of the natural biology of dendritic cells and their precursors, thereby allowing us to produce more potent dendritic cells in a more efficient and automated system."

https://www.prnewswire.com/news-releases/nw-bios-patent-portfolio-further-expanded-with-manufacturing-automation-patent-223111161.html