Replies to post #731294 on NorthWest Biotherapeutics Inc (NWBO)

[XMaster2023]

According to Gemini , Flaskworks could require a ISO 7 and/or ISO 8 clean room are classifications within the ISO 14644-1 standard for cleanrooms and clean zones. They define the level of cleanliness or the number of airborne particles allowed in a specific volume of air.
ISO 7 is a higher level of cleanliness than ISO 8. It requires fewer particles per cubic meter of air. This makes it suitable for applications that require a higher level of control over contamination, such as:
* Pharmaceutical manufacturing
* Medical device manufacturing
* Biotechnology research
* Microelectronics manufacturing
ISO 8 is a less stringent level of cleanliness compared to ISO 7. It is suitable for applications that require a moderate level of control over contamination, such as:
* General laboratory work
* Assembly of electronic components
* Food processing
Key differences between ISO 7 and ISO 8:
* Particle count: ISO 7 has a lower particle count limit than ISO 8.
* Air changes per hour: ISO 7 typically has a higher number of air changes per hour than ISO 8. This means the air is filtered more frequently, removing more particles.
* Environmental controls: ISO 7 cleanrooms often have more stringent environmental controls, such as temperature, humidity, and pressure, to maintain a clean environment.
Choosing the appropriate ISO class for a specific application depends on various factors, including the sensitivity of the products being manufactured, the level of contamination control required, and regulatory compliance.

I believe they are requiring an ISO 8 for Flaskworks which is similar to a general lab area that any hospital has.

[skitahoe]

I suspect that most major hospitals worldwide have cleanrooms and cryogenic capability. In some cases licensing staff to operate the EDEN Units and other needed equipment, then shipping the EDEN and as many of the disposable cassettes as needed to the site may be easier than transmitting material back and forth.

I know people here don't like this business model, but it would be a viable way to operate especially in some of the more remote areas around the world.

As I see it, if we truly gain approvals in multiple cancers millions of patients annually will need the vaccine. Divide the number patients that need the vaccine by roughly 50 and you'll know how many EDEN Units will be needed. I would think we'd be far better off with many production sites located strategically around the world rather than a massive cleanroom site in one, or a very few places.

Remember, the vaccine will probably also be stored where it's manufactured, then sent out in individual doses as needed for treatment. The logistics of having it all stored in one, or very few places could be a nightmare.

Gary