A Quantitative Approach to Potency Testing for Chimeric Antigen Receptor-Encoding Lentiviral Vectors and Autologous CAR-T Cell Products, Using Flow Cytometry

<b>Background/Objectives</b>: Potency testing of clinical-grade lentiviral vectors (LVVs) is critical to support a drug’s commercial approval. Careful consideration should be paid to the development of a suitable potency test during the drug’s clinical development. We aimed to develop an affordable,...

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Hauptverfasser:	Juan José Mata-Molanes, Leticia Alserawan, Carolina España, Carla Guijarro, Ana López-Pecino, Hugo Calderón, Ane Altuna, Lorena Pérez-Amill, Nela Klein-González, Carlos Fernández de Larrea, Europa Azucena González-Navarro, Julio Delgado, Manel Juan, Maria Castella
Format:	Artigo
Sprache:	Inglês
Veröffentlicht:	MDPI AG 2025-02-01
Schriftenreihe:	Pharmaceutics
Schlagworte:	chimeric antigen receptor potency testing T-cell activation analytical method validation ATMP development
Online-Zugang:	https://www.mdpi.com/1999-4923/17/3/303
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