Replies to post #494110 on NorthWest Biotherapeutics Inc (NWBO)

[Roman516]

Gerat post on Flaskworks,
Including your previous posts

"ski, you’re right that the Flaskworks system uses single-use disposables, but GMP rules are very explicit, and every facility will have documented procedures for regularly scheduled cleaning, sanitizing, inspecting, and maintaining of each piece of equipment and all work areas. The cleaning procedures will detail the type of cleaning agent, the pH, the strength, contact time for sanitizing the surface, what agent to clean off the sanitizing agent, etc. Detailed records will be kept of all these activities which report, not only proof of what cleaning took place, but who, when, and the outcome."

The GMP rules also support automation withing manufacturing facility, and this is certain a major advantage for the latest Flaskworks devices. Since each Flaskworks device has the ability to directly connect with a main data base control network, the entire process (7-days) can be monitored and recorded in real time including all cleaning process. Multiple Flaskworks units will be the key factor to support the growing number of patients that I hope will have access to all of NWBO's manufacturing facilities as they continue to move forward.

Roman516

[biosectinvestor]

Hi Hyperopia, I don’t think we can assume anything like that at this time, and it makes little sense for them to tie up the entire machine for each batch for days, but you certainly could be right. But that would generate zero new efficiencies and Flaskworks had claimed 10-15 times more productivity. I just think that assumption seems not consistent with any notion of any gain in efficiency that has been made. It would be no more efficient than a clean room except that it’s not a clean room. The value of the cartridges is that it should not take up productive space while the cells “culture”. Additionally, a reduction of 1 day, from 8 to 7 is not nothing, but not a huge gain in productivity, if it tied up all the machines for those days doing nothing when parallel processing should be easily accomplished. I suspect that observers of photos only, cannot possibly hypothesize what is likely going on as they commercialize a process that is being crafted to commercialize and industrialize the process and which uses enclosed cartridges to ensure that industrialization is possible.

We can only guess at this time, but the assumptions of people on social media are not consistent with claims of Flaskworks, and are not I think consistent with how such processes typically work in manufacturing.