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Kerebrad

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26/09/24

17:42

Post #: 75857052
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No doubt the FDA wants as much info as possible. They do get funded for 55% of everything they approve and up to 75% of selected products, by big pharma.
Big pharma would love to know whats going on behind closed doors. Nothing is for free.

(Still a bit bent and twisted from 2 x CRLs )

Originally posted by reginaldp ↑

Not what I wanted to read considering how long this damn process is taking- however it highlights the importance of the FDA saying "appears sufficient" to refile.

https://www.fda.gov/files/vaccines, blood & biologics/published/Cellular-Therapy-Products.pdf
SLIDE 23
So, the last thing to cover in this talk is the additional product characterization.
There is an infinite amount of characterization that you can do on any cell
product. FDA wants to try and gain as complete an understanding as is possible
of the cell therapy product.
So, sponsors are encouraged to look beyond just the simple lot release testing,
and include additional testing, such as a full panel of markers for phenotypical
analysis. They are also encouraged to look at gene and protein expression using
powerful assays, such as arrays, which gives you a large amount of data. FDA
also encourages sponsors to look at other parameters of purity and activity.
To make sure a sponsor really understands their product, it is suggested that
sponsors make use of these additional assays to conduct stability and
comparability testing, to make sure that they really understand that their product
is stable, and that their product is the same from before and after process
changes.
Often times the minimum lot release testing is not really sufficient enough to tell
you everything you need to know about the product.

Reg- looking forward to Rocktober

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Last edited by Kerebrad: 26/09/24

MSB Price at posting: $1.09 Sentiment: Hold Disclosure: Held
8 Upvote

1 Great analysis

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