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Thursday, September 23, 2021 8:24:32 AM
If what BSB is asserting is indeed true, then Advent is obviously handling the request for certification (not Northwest),
So from your response, I take it that you are surprised that it was Advent and not Northwest that submitted the request for the certification of the Sawston facility with the MHRA. Well, that makes two us. Also I find it a bit strange you still kinda doubt BSB, but thats besides.
Again, even your own quoted citation indicates that it is the "manufacturing and distribution sites"
This permits ADVENT and NOT NWBO to Practice Good Manufacturing (GMP) clinical grade medical products for patients IN THE SAWSTON FACILITY.
From the Advent website.
Advent Bioservices began activity as a cell therapy contract development & manufacturing organization in 2016 and is in the process of building a state-of-the-art multiproduct GMP production facility outside Sawston in Cambridgeshire, which will allow the scale up of current commercial production and the provision of contract manufacturing services to meet the growing demand for such services in the UK. Methods, Results & Conclusion
Advent Bioservices is currently in the process of applying for licencing and accreditation from UK authorities including the HTA, MHRA and HFEA for the Sawston site.
Ok now lets go over some analogies it helps
1. What If Advent in theory were to get bankrupted?
a. Would then NWBO still be permitted to Practice Good Manufacturing (GMP) clinical grade medical products for patients in the Sasston facility?
b. Or do they have to go through the same MHRA process with another crew/company?
Please answer
2. You never answered this:
a. If Northwest were to sell the Sawston property to Barclays is Barclays then now a CDMO/GMP?
b. Is NWBO after certification of Sawston a CDMO/GMP?
c. Is the owner of the property in London the smaller King’s College lab a CDMO/GMP? Probably some pension fund, Im sure they are happy to learn that apparently, they are now a CDMO/GMP... lol
Please answer
3.
But carrying out your own analogy further, it is Northwest that owns the plane, not the pilot. Northwest has hired a certified pilot to fly the aircraft certified plane that has been determined to be in airworthy condition.
The leasing company leasing out airplanes and Advent the airliner. Yes airliner.
which will allow the scale up of current commercial production and the provision of contract manufacturing services
Conclusion:
1 advent is the CDMO/GMP in the Sawston facility NOT NWBO. NWBO does not have permission to produce a bloody aspirin
On May 7, the application package was submitted to the MHRA requesting the certification of the Sawston facility to produce Good Manufacturing Practice (GMP) clinical grade medical products for patients
2. With a theoretically bankrupted Advent Sawston would just be a facility with all the interior and equipment but with a revoked certification. They would have to go through all of that again
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