Bringing function to the forefront of cell therapy: how do we demonstrate potency?
Unlike conventional pharmaceuticals, biologics and Advanced Therapy Medicinal Products (ATMPs) are required to meet a standard of “potency” as part of the final release criteria at completion of manufacture. During early phase clinical trials, most regulatory agencies have been willing to accept ver...
Main Authors: | , |
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Format: | Article |
Language: | English |
Published: |
Frontiers Media S.A.
2023-07-01
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Series: | Frontiers in Immunology |
Subjects: | |
Online Access: | https://www.frontiersin.org/articles/10.3389/fimmu.2023.1226841/full |