Replies to post #402941 on NorthWest Biotherapeutics Inc (NWBO)

[vator]

You keep on the same theme. But we hire Advent to get the site certified. Just as we hire independent testing labs, universities, consultants indirect and direct.

[MI Dendream]

I am no expert here, but it seems this debate about manufacturing license despite being referenced by some materials is based on opinion at this point. I will weigh in with what little experience that I have to base my opinion on.

Long ago, I worked part time in a lab for a US-based generics manufacturer undergoing certification. My understanding is that the license covers both the site and the process. When the review is done the facilities are inspected as are all of the QA, QC, Validations, and Stability SOPs against the data produced for the certification batches run. Things looked at are stuff like ingredients storage procedures, actual human work flow, temperature stability for any in-process elements as well as storage locations throughout floor to ceiling, East to West, center to corner

The two are hand in hand, the facility and the process. The license can be managed by a new service provider when necessary so long as the same process is followed, tested and documented. IMO