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Posted On: 02/24/2021 11:29:08 AM
Post# of 36568
They started the GMP manufacturing process 4 months ago. There was a PR about it.
What is involved:
Each iikey peptide gets manufactured and engineered runs 3 separate times with 30 day stabilization testing in between each run to confirm the process of manufacturing is identical/standardized. The run quality has to be measured and be consistent. This info has to be included in the IND as well requirements in 100's of pages of manuals describing how to manufacture etc.
I'll send the links to the manuals in a bit. Not that anybody wants to read them.
What is involved:
Each iikey peptide gets manufactured and engineered runs 3 separate times with 30 day stabilization testing in between each run to confirm the process of manufacturing is identical/standardized. The run quality has to be measured and be consistent. This info has to be included in the IND as well requirements in 100's of pages of manuals describing how to manufacture etc.
I'll send the links to the manuals in a bit. Not that anybody wants to read them.
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