Potency assays for advanced stem cell therapy medicinal products
Éditeur :
Springer International Publishing AG
ISBN :
9783031300424
Date de publication :
19 juin 2024
Dimensions :
25,4 x 17,8 cm
Langue :
Anglais
Pays d'origine :
Suisse
The first few chapters introduce a nuanced historical perspective on the science of potency assay development, describe specific quality attributes of an idealized potencyassay, indicate pitfalls associated with developing such assays for ATMPs, and review guidance recommended by regulatory authorities on assay suitability for product approval.