Replies to post #428371 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

The process used would entail the chemicals added in the exact amount, incubation times and temperatures, the cytokine profiles tested and acceptable range of the output

What is 'validated and approved' is a facility's ability to control and repeat these process critical parameters.

The 'exact amount' of chemicals added, etc, are not part of the cert. You just have to demonstrate the capability to to put exactly what the procedure calls for into the process at the right time and condition. The order of magnitude is part of this equation as well, as the ability to maintain a tolerance of +/-0.5% is very different at the microgram scale when compared to the kilogram scale.

I will say I'm speaking strictly from a US experience with pharmaceutical facilities. But I imagine this process is almost identical, and from what I've studied up on it so far this seems to be the case.

Either way, I am truly not trying to 'minimize' this accomplishment at all. I feel I have been more than generous in my praise of this milestone, it is fantastic news; I do not think anything I have said would imply otherwise.