NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Jack2479,

Thank you for the information! I agree 100%.

You said that you visited the Sawston facility late last year and spoke to the team at Advent. Did they told you they want to receive GMP license for a closed production system used to manufacture their lead product?

I ask you because Advent Bioservices is working with Autolomous.
And a month ago Glycostem Therapeutics announced they have chosen Autolomous for the digitisation of the manufacturing and release of Glycostem's NK-cell therapies for clinical trials and beyond.

Glycostem Therapeutics
947 followers
1mo • 1 month ago

Digital, effective, eco-friendly, and powerful – Glycostem will implement Autolomous AutoloMATE platform to digitise manufacturing and release of oNKord®, for clinical trials and beyond. The AutoloMATE platform will be tailormade for oNKord® manufacturing process in our state-of-the-art in-house and GMP licensed facility. This change will drive efficiency throughout the capturing / review and release of manufacturing data and leverage leading edge technologies such as distributed ledger technologies, IoT and AI. Glycostem is reinforcing its commitment to GMP aspects of cellular immunotherapy while supporting difficult to treat cancer patients.
https://www.linkedin.com/company/glycostem-therapeutics/

https://www.linkedin.com/feed/update/urn:li:activity:6673855756040843264/

So, they must be impressed by the work of the Autolomous team! And the only other Autolomous customers are Advent Bioservices and UCL = team of Mark Lowdell who work at the same cleanroom suite as Advent. https://www.autolomous.com/partnership

The interesting thing is that a year ago Glycostem Therapeutics BV has announced that they have received GMP license for Glycostem’s proprietary closed production system used to manufacture their lead product, oNKord®, an off-the-shelf,allogeneic Natural Killer(NK) cell therapy. It was also a unique event in the cellular therapy sector as it was the first inspection leading to approval of a closed allogeneic cellular production system in a class-C cleanroom.

25th June 2019 - Glycostem Therapeutics BV today announced they have received GMP license for Glycostem’s proprietary closed production system used to manufacture their lead product, oNKord®, an off-the-shelf,allogeneic Natural Killer(NK) cell therapy.
Troels Jordansen, CEO said “This is a key milestone for Glycostem as it allows us to progress with our pivotal clinical trials in Acute Myeloid Leukemia (AML) to be followed by Multiple Myeloma (MM), two life-threatening hematologic malignancies with severe prognostic. But it is also a unique event in the cellular therapy sector as this is the first inspection leading to approval of a closed allogeneic cellular production systemin a class-C cleanroom.This major achievement allows for oNKord® production in class-C clean room which is more cost efficient than in class-A/B clean rooms; both in set-up and running costs.
https://www.glycostem.com/node/172

Some information about the production process of Allogeneic NK cells for Cancer Immunotherapy - oNKord®:

The production process yields in a high quality of oNKord®based on:
• The ex vivo cultured NK cells have a similar composition and
functionality as in vivo NK cells.
• The system is closed, assuring a low risk of contamination.
• The system is very efficient and effective. The process
generates a superior expansion of NK cells: 5-10,000 fold
expansion is achievable.
• The system produces unprecedented high numbers and also very
pure NK-cells: up to 10 billion per batch that are over 95% pure
and devoid of contaminating T- and B-cells, which frequently
play a role in the mortality associated with allo-SCT and would
be similarly problematic in NK cell infusions.
• The produced NK cells are activated and 'ready to attack cancer
cells'.
• The output has been proven to be highly reliable & reproducible.

That’s one of the reasons why I suspect that they want to receive GMP license for a closed production system used to manufacture DCVax-L at Sawston. I wonder if you have any concrete information?

NOTE : Glycostem Therapeutics is working with Fraunhofer IZI:

Dec. 2018. Over the next 4 years Glycostem in, as part of the consortium led by Prof Ulrike Köhl from Leipzig, work on developing novel methods to manufacture tumour reactive NK cells. The consortium consists of nine academic centres covering basic and translational research, as well as 3 leading biotech companies (Innate Pharma, Miltenyi and Glycostem) and Fraunhofer IZI as a world leading research institute. The objective is to educate top level selected PhD candidates not only in science, but also have a strong focus on business and management activities as well as basic and advanced knowledge in strategies around intellectual property.https://glycostem.com/node/150