Cell Therapy Concentration vs Dosage Form

[joao4515]

#25020

Hello fellow Stabilitarians!

As a general question regarding cell therapies, if there is a target dosage for the cell density and volume (i.e. product spec = 1.0 x10^6 cells/mL) how tight does our dose need to be to the spec? Is a +/- of 20%, 30% or 50% relative to the spec considered acceptable by regulators? Would I need to initiate 3 separate studies for mid, high and low dosage forms based on the target dose and each dose from the +/-?

Where is that line drawn in such a new area in the pharma industry?

[John O’Neill]

#25026

Excellent question and I’m glad to find it posted here on StabilityHub. Cell therapy stability is among the very latest challenges to our ranks and wide experience is still lacking. That makes sharing information all the more important and I hope those in the know will step up to share their knowledge.
John O’Neill
StabilityHub Editor

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