Replies to post #684792 on NorthWest Biotherapeutics Inc (NWBO)

[newman2021]

The subtle news here is beartrap that Mike Scott already figured out putting together those GMP components and a dozen FWs in a suit C room which might already be manufacturing a few 1000 vaccines a year, imo. All this credit absolutely goes to LP as she had the vision of this some 7 or 8 yrs ago. Recall she built the Cognate for supplying the vaccine to meet the demand for the phase 3 trial; Dr. B and Liau did the lab version of the vaccine but LP took it to the large scale manufacturing. Chiugray says a lot of good things about it. And TDD says we are KingMakers. All are happening now, kudos to all of us.

[CaptainObvious]

I look at the 'supply chain issues' as a flimsy excuse at this point, but overall it's good news.

[sentiment_stocks]

Thanks, beartrap, for bringing some of the facts from the recent Flaskworks PR back to our attention.

As soon as the GMP-grade units are delivered, Advent BioServices will undertake final qualification and validation of the GMP units and use engineering runs with the system to collect data in order to submit an application to regulators to approve the use of the system for production of DCVax-L for patients.

Yes, this quote definitely states they are making multiple units. I also liked the later part of that sentence I’ve highlighted in bold, as I read it as them being fairly close in the process to being able to use these Flaskworks machines to make DCVax-L upon an MAA approval… and that will likely be very helpful in garnering NICE financial support.

I don’t really know exactly what an “engineering run” is, so I googled it and found this,

An Engineering Run can be also called many other names such as an engineering trial run, engineering lot or practice runs or demonstration runs but they are usually non-GMP runs used to demonstrate that the manufacturing equipment and processes work as required and that the end product can meet the required quality specifications.

https://www.bluehatchconsultancy.com/tech-transfer-9-engineering-batches/#:~:text=An%20Engineering%20Run%20can%20be,meet%20the%20required%20quality%20specifications.

I know we have quite a few engineer types here so perhaps they will weigh in.

:)

[ccie1024]

So right from the get-go we'll have more than one EDEN unit up and running when/if MHRA approves the unit.

They’re still prototypes, which suggests something that may be further developed before becoming final.

EDIT: could be interpreted both ways, I suppose.