Replies to post #550266 on NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

Thank you hyperopia for your excellent description of the three processes that Flaskwork's Eden system must go through before its use in the commercial production of DCVax. What I find intimidating is the possibility that the system's validation may not have as yet been achieved. Hopefully, the completion of this process will not take many more months and if there is a substantial delay, I hope that at least by ASM time, we will get an update concerning this matter.

[Roman516]

Great information based on the Flaskworks (EDENS) device
Here is so additional information to support your comments
" Most of the automated commercial equipment available from vendors will come with a validation package (including its computer system), however, the Flaskworks’ Eden is a bespoke system which does not, so its validation (including its software/firmware code) will call for closer scrutiny. This (and the software/validation job openings) is what leads me to believe (if there was an issue) there may have been more validation work to do on the Flaskworks system."

Current Openings at Advent
“Thanks for checking out our job openings. See something that interests you? Apply here.
Job Location Description
Biobank Technician Sawston Production
GMP Production Scientists London and Sawston Production
Validation Specialist Sawston Quality Assurance”
Source:
https://adventbio.peoplehr.net/JobBoard/

“What is a Bespoke system/software?
Bespoke system
A bespoke system is a set of computers, laptops, or electronic devices customized to the client's demand. Companies like Dell, HP, and Apple provide their clients with options to customize the system they purchase. For example, a video editor may order to build his system with a high-end graphics card for video production. On the other hand, another may add additional RAM to her computer to support multiple tasks.”
Bespoke software
A bespoke software (or custom software) is a software development solution built for the client's specific requirements. Bespoke software is created just for you and, therefore, will satisfy all of your company's demands. You won't need to change your present workflow in order to use these customized solutions because they were developed to do so. The solution can easily be linked with other bespoke or off-the-shelf software used to replace an outdated system. You can also upgrade or expand in the future because it is customized to your particular business, and you own the source code. Bespoke is considered an alternative to ready-to-use software or "off-the-shelf" software.”
“Bespoke software is Adaptability, Flexibility, Agile

Bespoke software is adaptive, flexible, and agile in contrast to off-the-shelf software since it is built and can be changed as needed along the development process. You can expand, improve, and adjust the features without having to start from scratch.

Adaptability - Using bespoke software solutions makes it simpler to target the right audience. Clients are happier when a website or application's features exactly meet their needs and requirements.
Flexibility - Customization enables you to create features and functions that are aimed at your target market. Bespoke software is flexible in the way it allows the creation of an intuitive user interface. Along the development process, the features and functions are altered and updated; you can always go back and change, enhance, add, or delete them as necessary.
Agile - With the proper implementation, bespoke software raises the product's quality. Designers are free to experiment, make corrections, and pick up where they left off without affecting the project's early phases. Your team may make adjustments during the development phase, guaranteeing complete client satisfaction at 100%.”
Source:
https://www.linkedin.com/pulse/bespoke-system-software-what-use-2022-son-chu-

It is imperative to understand that the Flaskworks (EDENS) unit is a complex device and will enable NWBO's manufacturing to be able to deliver increase production volume significantly over current manual process. The good news is that Regulatory Agencies prefer Adaptive manufacturing process to be able to analyze and fix problems on the fly and thereby ensure a more stable production process. NWBO's manufacturing partners are on the right path, IMPO.

[antihama]

You’re probably right that the Eden system will be submitted as a Supplement to the MAA but I’m still thinking due to the length of time it seems to be taking that they are looking at it as part of the MIA certification process and then it will be part of the initial MAA submission and not part of a supplemental MAA. I hear you that the commercial process is looked at more carefully but I believe/hope they started the Comparability Protocol process much earlier say 1st-2nd Q 2021 after getting the Fife loan in Nov 2020 where NWBO said it will be used “to help accelerate its activities related to its brain cancer program”.

Secondly, my thought is that Sawston has already shown they have GMP Quality Systems in place after the previous recent inspections and any additions such as Eden will be done via their Quality Systems. So, when they look at the Eden computer setup, Sawston will provide documentation that shows this. From my experience that’s what the Inspectors will be looking at. Caveat; my experience is from when Part 11 regs just came out and I know things have moved forward a lot. They have SOPs/Validation protocols in place indicating what is required and to be tested and they provide documentation to show that they did that. The only thing I’d be concerned w regards to its software/firmware code is to make sure that it cannot be manipulated and that they tested for that as part of their requirements. And Advent would have initially performed due diligence inspections looking at those bespoke vendors and have documentation to show they did that. I guess I’m looking at it that since Advent recently underwent inspections where the MHRA looked at their Quality Systems, I have faith that Advent will continue to pass the test rather w/o too much difficulty. Was hoping we’d get a PR today to make this discussion moot but its still fun to talk about this.