This was a very well written article. Having spent decades as a supplier auditor for the pharmaceutical industry, buffer suppliers are not required to be GMP certified. Although the firms I have worked for would expect our suppliers to have good practices including cleaning, etc. It is unknown what specific use PFZ or Moderna were using the buffers for like Research & Development or as early precursor activity that then undergoes further refinement. Excipients used in injectable formulations have strict pyrogen and endotoxin testing requirements - for further reading you can reference the United States Pharmacopeia Chapter on Bacterial Endotoxins.
The comment above was authored written by R. Miller
This is a brilliant piece bringing the lawsuits together in the context of the serious nature of this mould contamination. Well done
A picture worth a thousand words
Insanity!
The dark , sick rabbit hole keeps getting deeper. Nothing surprises at this point.
This was a very well written article. Having spent decades as a supplier auditor for the pharmaceutical industry, buffer suppliers are not required to be GMP certified. Although the firms I have worked for would expect our suppliers to have good practices including cleaning, etc. It is unknown what specific use PFZ or Moderna were using the buffers for like Research & Development or as early precursor activity that then undergoes further refinement. Excipients used in injectable formulations have strict pyrogen and endotoxin testing requirements - for further reading you can reference the United States Pharmacopeia Chapter on Bacterial Endotoxins.
The comment above was authored written by R. Miller
I am not surprised! How anyone can trust them is unbelievable!