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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...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Frontiers Media S.A.
2023
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10366357/ https://www.ncbi.nlm.nih.gov/pubmed/37497223 http://dx.doi.org/10.3389/fimmu.2023.1226841 |