NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

In my conversations with DI, what I have deduced, and caution this is MY personal opinion on what I heard, is that they are already testing Flaskworks on their own; in a parallel stream to vaccine creation testing/training via standard clean room technology. I believe they are targeting end of Q1, early Q2 2022 completion for Flaskworks certification.

Who do you think is testing Flaskworks on their own? How? And where?

It doesn’t require duplication, or make sense to me. Advent has been contracted to test the system, and when it has been sufficiently tested, to perform the equivalency study and develop the new automated process. They have the knowledge, skill, and facility.

Instead, what makes more sense to me is that the technical team from Flaskworks has been working to develop the MicroDEN device into a commercial manufacturing system. MicroDEN was designed for clinical use, potentially to lower the cost for clinical trials, but it’s not ideal for commercial production. Shashi Murthy understood this and described a number of features in the patents that would likely be necessary for commercial production. From the patent:

Cell culture systems are configured with interchangeable cartridges, allowing versatility and scalability. Systems are configured to have multiple connected cell culture chambers, which allows parallel processing. . .

Certain aspects of the invention are directed to methods of determining a cell culture protocol. The methods comprise receiving data associated with cells to be cultured; connecting to one or more databases to receive data about cell culture protocols; and determining a cell culture protocol for the cells to be cultured.

In some embodiments of the invention, methods further comprise updating the cell culture protocol based on feedback during cell culture. The feedback is from one or more sensors disposed on a cell culture apparatus and communicatively coupled with a controller. In some embodiments, the feedback is associated with at least one of pH, glucose concentration, lactate concentration, dissolved oxygen, total biomass, cell diameter, temperature, cell type, media type, and fluid flow rate.

So the commercial system may have multiple culture chambers and pumps running in parallel to be able to culture multiple treatments (10-12?) at the same time, and have multiple sensors to be able to monitor and control the culture process in real time. And this system will have be integrated with the Autolomous, AutoloMATE software that Advent will be using at Sawston, which digitizes workflows, maintains electronic batch manufacturing records, and tracks the batch throughout the manufacturing process, as well as Autolomous’ CLOCK scheduling software that coordinates the entire supply chain; hospitals for patient leukapheresis and dosing, logistics transporters, and the manufacturing equipment.

And what further makes me think at least some development work has been achieved, is that I kinda doubt that Michael Bigger would say the following about the former MicroDEN system:


Michael Bigger @biggercapital
Oct 8
In awe with FLASKWORKS potential.

Oct 10
Thought Experiment: Clean Room Disruption? FLASKWORKS. Solid Tumors Disruption? DC-VAX. Inoperable Solid tumors disruption? DC-VAX Direct ,,, and then some. Is someone in the room playing a very long game?

Oct 10
Why is FLASKWORKS so important?