You mentioned a 'paywall' but there's a video by "Wong, D" (Dennis Wong) discussing the new testing stuff with AstraZeneca goons which can be accessed by simply putting in a "name" and "email address" (up to you if you provide accurate details or not):
- 1 site used 'Endosafe-MCS' technology, 2 used gel-plate, 7 used plate readers.
- Variable testing with variable sample volumes, variable sensitivity, etc.
- Issues at testing sites; invalid sample rate variable over sites, tests being repeated
- AZ proposed switching to 'Endosafe-MCS' (manufactured by Charles River, the host of the video)
- Complains about 'regulatory burdens' regarding other forms of testing. Puts "water" in quotation marks for some reason.
Other issues noted (~21:00 in the video):
- Nexus audit trail issue: Users able to delete and change entries without permissions
- Sample dilution issue, "software bug"
- Collision risks involving a robot arm (?)
- Damage in transit (somehow a labelling issue?)
- "Faulty Hamilton system at one site"
AZ's justification is "cost" and the poor, poor horseshoe crab (as if pharmaceutical companies ever gave a flying shit about animals), but the buried implication is the inaccuracy and inconsistent testing.
I don't profess to understand endotoxin testing technology, so you will want to review the video yourself to see if there are any obvious red flag I may have missed.
You mentioned a 'paywall' but there's a video by "Wong, D" (Dennis Wong) discussing the new testing stuff with AstraZeneca goons which can be accessed by simply putting in a "name" and "email address" (up to you if you provide accurate details or not):
https://www.criver.com/resources/webinar-pi-ms-astrazenecas-lessons-learned
Details from video that might be of interest:
- 1 site used 'Endosafe-MCS' technology, 2 used gel-plate, 7 used plate readers.
- Variable testing with variable sample volumes, variable sensitivity, etc.
- Issues at testing sites; invalid sample rate variable over sites, tests being repeated
- AZ proposed switching to 'Endosafe-MCS' (manufactured by Charles River, the host of the video)
- Complains about 'regulatory burdens' regarding other forms of testing. Puts "water" in quotation marks for some reason.
Other issues noted (~21:00 in the video):
- Nexus audit trail issue: Users able to delete and change entries without permissions
- Sample dilution issue, "software bug"
- Collision risks involving a robot arm (?)
- Damage in transit (somehow a labelling issue?)
- "Faulty Hamilton system at one site"
AZ's justification is "cost" and the poor, poor horseshoe crab (as if pharmaceutical companies ever gave a flying shit about animals), but the buried implication is the inaccuracy and inconsistent testing.
I don't profess to understand endotoxin testing technology, so you will want to review the video yourself to see if there are any obvious red flag I may have missed.
That is great, thanks. What I am looking for is actual measurements of Endotoxin expressed as EU/ml. Did you see any numbers accidentally flashed up?
I don't think AstraZeneca are going to wilfully convict themselves putting the toxicity levels out there.
I'll have a dig, but just assume I won't find anything for the time being. Unfortunately the EMA leaks only relate to Pfizer.