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Post# of 703846
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Smokey21

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Smokey21

Re: ae kusterer post# 551430

Wednesday, 12/21/2022 9:07:28 AM

Wednesday, December 21, 2022 9:07:28 AM

Post# of 703846
I'm wondering if the two areas that were added to the IMP just approved have anything to do with approval of the Flaskworks process?
[ 1.6.1 ] Microbiological: sterility
[ 1.6.2 ] Microbiological: non-sterility
It would make sense to update the existing authorization for investigational products to include that capability if the process has been automated now, where it was manual before.

Just a thought. I guess we'll see when the Manufacturing Authorization comes through for Human and the company gives us more details.
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