Analysis of the measurements used as potency tests for the 31 US FDA-approved cell therapy products

Analysis of the measurements used as potency tests for the 31 US FDA-approved cell therapy products

Abstract Cell therapy product (CTP) developers face the significant challenge of developing appropriate potency tests for their CTPs. A review of the known potency tests used for the 31 United States Food and Drug Administration-approved CTPs (US FDA) can guide developers in designing effective pote...

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Bibliographic Details
Main Authors: Carl G. Simon, Erich H. Bozenhardt, Christina M. Celluzzi, David Dobnik, Melanie L. Grant, Uma Lakshmipathy, Thiana Nebel, Linda Peltier, Anthony Ratcliffe, James L. Sherley, Glyn N. Stacey, Rouzbeh R. Taghizadeh, Eddie H. P. Tan, Sandrine Vessillier
Format: Article
Language:English
Published: BMC 2025-03-01
Series:Journal of Translational Medicine
Subjects:
Cell therapy product
Potency
Potency test
Regenerative medicine
Online Access:https://doi.org/10.1186/s12967-025-06253-4
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https://doi.org/10.1186/s12967-025-06253-4

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