NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Sentiment,

I can not prove it, but I strongly believe that the Germans used a closed system for the manufacture of DCvax-L.

I learned that years ago (2012-2013) researchers from the Ghent University Hospital developed a new generation of DC vaccines and they used a completely closed system.
The Ghent University Hospital is located 25 miles from Brussels, the capital of Belgium and of Europe.

Note: Belgium is a neighbor of Germany and Ghent is 130 miles from Cologne (Germany).

Note:The production of the vaccine looks very similar to the production of Dcvax-L.
Some quotes from the Ghent Clinical Immunology, therapeutic & diagnostic platform:

“2011 also saw the birth of Ghent Clinical Immunology: a multidisciplinary platform supported by Ghent University Hospital, integrating clinically-oriented research efforts in the field of cellular immunotherapy and advanced immunological diagnostics.”
http://clinicalimmunology.ugent.be/page2/index.html

“the immunogenic power of the DC can be tamed to produce a cellular vaccine.
This concept opens unique opportunities for the treatment of cancer. Laboratories around the world have come to the same conclusion: cancerous growth can indeed be restrained by properly activated immune cells. Countless experiments have even demonstrated complete and selective eradication of cancer cells by the immune system.
With this knowledge, the idea was born to generate large amounts of dendritic cells from the blood of cancer patients, to activate these cells in vitro and to load them with extracts (“antigens”) from the patients’ tumor. This DC vaccine is then injected back into the patient. The aim is to have the activated DCs teach sufficient amount of killer lymphocytes to go seek and destroy cancer cells.”
“Thanks to support from Ghent University Hospital's “spearhead research initiatives”, the Foundation against Cancer, the Flemish League against Cancer and the IWT (Flemish agency for Innovation by Science and Technology), we are now developing a new generation of DC vaccines”.
http://clinicalimmunology.ugent.be/page10/page5/index.html

Below the page you find pictures how DC cancer vaccine prototypes were produced at Ghent University Hospital.

“The cells are run through the CliniMACS device, which uses magnetic fields to extract the monocytes in a completely closed system. The result is a cell bag containing 99% highly viable monocytes.”

About Fraunhofer IZI, first this comment: the building projects of the Fraunhofer IZI are sponsored 60 percent by the European Union and 20 percent each by the Federal Ministry of Education and Research and the Free State of Saxony. In the same manner, the expenses of about 11 million Euros for construction and equipment of the extension building were covered.( Fraunhofer IZI Annual Report 2014 P.167 )https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Publications/Annual_Report_IZI_2014.pdf

I think Fraunhofer is the most valued research center in Europe!

Look at the equipment GMP Cell and Gene Therapy-IZI Fraunhofer. They have a CliniMACS Prodigy® device! (remember at Ghent University Hospital the cells were run through the CliniMACS device in a completely closed system).
https://www.izi.fraunhofer.de/en/departments/leipzig-location/gmp-cell-and-gene-therapy.html#tabpanel-3

Of course, i can not prove the Germans used a CliniMACS device to produce Dcvax-L!

More about CliniMACS Prodigy®:

The CliniMACS Prodigy® is a closed and automated platform with the capability to manufacture various cell types on a single device and within a single process setup. It delivers consistent product quality in every batch enabling reproducible cell production.
The closed system eliminates open processing steps and unnecessary operator transfers between multiple devices. Thereby, the contamination risk and associated quality variation from human intervention is significantly reduced.
https://www.miltenyibiotec.com/BE-en/products/cell-manufacturing-platform/clinimacs-prodigy.html

For me it seems very unlikely that the Germans used an open system to make the vaccine.
And on the other hand you also have the Hospital Exemption and the strict Regulatory notes!
For those who are interested in HE, you can find a lot of information in this Master Thesis, Dr. Anna Schnitger: The Hospital Exemption, a regulatory option for unauthorised ATMP's.

The Master Thesis is from 2014 but you will also find some information about Dcvax-L and HE.

http://dgra.de/media/pdf/studium/masterthesis/master_schnitger_a.pdf
Best Wishes!