NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Dog Logic,

Thank you! Maybe here is some more evidence that the TFF Cell Separation System is in use in Europe.

For newbies reading this post. A more potent vaccine comes from a 8 day TFF process, which will equate to a both a higher quality and higher reliability DCVax-L personalized product for 3-5 years. TFF= Tangential Flow Filtration machines

http://www.nwbio.com/nw-bios-patent-portfolio-further-expanded-with-manufacturing-automation-patent/

From SEC 10K released in 2008 we learned that the TFF-Cell Separation System is also targeted to be implemented into the DCVax®-Brain product after bioequivalence studies have been completed. Since the product economics are favorable even with the existing first generation manufacturing process, the Company intends to only implement the TFF-Cell Separation System at a time and in a manner that does not interfere with the pivotal Phase II clinical trial for DCVax®-Brain, or product approval or launch.

https://www.sec.gov/Archives/edgar/data/1072379/000089102008000094/v37359e10vk.htm

From Northwest Bio Presents at Phacilitate Immunotherapy World 2015.
January 26, 2015 - Washington, DC - The CEO of Northwest Biotherapeutics Linda Powers speaks on the topic of "Personalized Approaches to Immune Therapy."

Slide min. 21:

DVAX-L/ Cost-Effective, Rapid Batch Manufacturing.

DAY 1: Tumor tissue & blood at manufacturing facility
DAY 2 : Precursors of dendritic cells isolated
DAY 2-7: Precursors differentiated into dendritic cells
DAY 7: Dendritic cells “educated to exposure to biomarkers from tumor tissue
DAY 8: “Educated “ dendritic cells harvested & frozen. Manufacturing finished. (Release tests follow)
Single manufacturing run yields 3-5 years of doses of DCVAX-L product. Only 2 grams of tumor tissue needed for full batch. With < 2 grams of tumor tissue, a partial batch can be produced.

Min 21.20

DCVAX: Operationally Practical for Commercialization.

Linda powers said:

“It’s a major world of technology and we’ve spent 10 years working on that. We validated the frozen shelf life and potency to the satisfaction of regulators in three countries, the USA, Germany and UK, and it is a very practical product. We only ever do manufacturing once per patient. We manufacture three to five years worth of doses in that eight days manufacturing run ……we have worked long and hard with the batch manufacturing to make it very cost-effective and it will be in line with other cancer drugs. We’ve been in reimbursement discussions in Europe for a number of months now.”