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Re: meirluc post# 794765

Saturday, 10/25/2025 9:57:03 PM

Saturday, October 25, 2025 9:57:03 PM

Post# of 821111
No need for another MHRA audit in 2026 since the EDENS Flaskworks units has been tested and they should already functional, IMPO.

Old news
https://www.wtrf.com/business/press-releases/cision/20240206SF30140/northwest-biotherapeutics-moves-from-optimization-of-flaskworks-prototype-to-fabrication-of-gmp-compliant-units-for-installation-validation-and-final-testing-prior-to-regulatory-certification/

As mentioned, per my former posts,

Roman516

Re: ilovetech post# 793148

Saturday, October 18, 2025 12:08:58 PM

Post#
793236
of 794768
Flaskworks units based on advance AI Software and Hardware control

Just some additional support information to help board members understand the advanced capabilities for the new Flaskworks units.
Each Flaskworks unit has a microprocess controller IC whereas the microprocess has several dedicated communications ports to enable each Flaskworks to link up with higher level controller network system. The higher-level controller network system is able to use advanced AI software to improve that overall performance for each Flaskworks unit. In addition, each Flaskworks units utilize a PLD programmable Logic Array and are able to adapt to the Flaskworks hardware and in some cases the PDLs can be remotely reconfigured to update and improve the hardware performance capabilities.

1) Automatic programing and record capability for each vaccine production.

2) High speed communications capability for each Flaskworks units to communicate with more advanced level network systems

https://www.bing.com/search?q=microprocess+communications+links+to+high+level+controllers&form=ANNTH1&refig=68f3b387bf194118b0b6a7f0df419462&pc=HCTS

3) Able to adapt to each vaccine production for maximum likelihood for best quality results.

https://www.bing.com/search?q=maximum+likelihood&form=ANNTH1&refig=68f3b034f9034b8d82b47a1668919e88&pc=HCTS&pq=maximum+lick&pqlth=12&assgl=18&sgcn=maximum+likelihood&qs=SC&sgtpv=SC&smvpcn=0&swbcn=10&sctcn=0&sc=10-12&sp=2&ghc=0&cvid=68f3b034f9034b8d82b47a1668919e88&clckatsg=1&hsmssg=0

4) Utilization of advanced PLDs for maximum hardware optimization capabilities.

https://plcblog.in/plc/plc/plc-communication-types-and-protocols.php
https://link.springer.com/chapter/10.1007/978-94-009-7007-6_11

The good news is that the more each Flaskworks units are in production, the greater the manufacturing optimization should occur. This is a win-win for NWBO and all its manufacturing facilities. With advanced AI software, the software will be able to adapt performance capabilities as well as the use of PLAs to optimize the hardware capabilities. In all, NWBOs manufacturing could be at the CMMI level 5 capabilities. As a scientist working with manufacturing regulatory agencies for over 35 yeas, these RAs support CMMI-5 based on maximum manufacture capabilities, IMPO. In NWBOs case, this advanced manufacturing should help both MHRA and FDA knowing that NWBO has an advanced process to enable their manufacturing facilities to provide maximize quality for vaccine production, IMO

https://www.bing.com/search?q=cmmi+model&form=ANNTH1&refig=68f3b3c4841f4c0881e965ae64dd83cd&pc=HCTS&pq=cmmi&pqlth=4&assgl=10&sgcn=cmmi+model&qs=EP&sgtpv=EP&smvpcn=0&swbcn=10&sctcn=0&sc=10-4&sp=1&ghc=0&cvid=68f3b3c4841f4c0881e965ae64dd83cd&clckatsg=1&hsmssg=0

Overview of CMMI
CMMI is a proven set of global best practices designed to improve business performance by building and benchmarking key capabilities. Originally developed for the U.S. Department of Defense to assess software contractors, CMMI has since expanded to help organizations across various industries improve their processes and performance

https://www.bing.com/search?q=cmmi+model&form=ANNTH1&refig=68f3b3c4841f4c0881e965ae64dd83cd&pc=HCTS&pq=cmmi&pqlth=4&assgl=10&sgcn=cmmi+model&qs=EP&sgtpv=EP&smvpcn=0&swbcn=10&sctcn=0&sc=10-4&sp=1&ghc=0&cvid=68f3b3c4841f4c0881e965ae64dd83cd&clckatsg=1&hsmssg=0

All the more that NWBO is moving forward with a solid path to ensure that each patient is receiving the most optimized vaccine product capability available, IMPO
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