“So I was wondering if China partners were indep
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Posted On: 03/18/2021 2:13:49 PM
“So I was wondering if China partners were independently developing GMP production of the vaccine.”
That’s an item I talked to Joe about yesterday. They aren’t, nor would that be wanted. Generex is the sponsor. I’m trying to recall off the top of my head, but there’s three GMP engineering runs. The stability tests on them need to be within 1 or 2% match. Once Generex has that accomplished for their manufacturing runs that’s what he called their “secret sauce”. They send that sauce within the IND to the FDA and their international partners. You can’t have someone else doing similar and being a percentage off if I recall correctly. Everything moves faster after this process is completed.
That’s an item I talked to Joe about yesterday. They aren’t, nor would that be wanted. Generex is the sponsor. I’m trying to recall off the top of my head, but there’s three GMP engineering runs. The stability tests on them need to be within 1 or 2% match. Once Generex has that accomplished for their manufacturing runs that’s what he called their “secret sauce”. They send that sauce within the IND to the FDA and their international partners. You can’t have someone else doing similar and being a percentage off if I recall correctly. Everything moves faster after this process is completed.
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