Optimized Assessment of qPCR-Based Vector Copy Numbers as a Safety Parameter for GMP-Grade CAR T Cells and Monitoring of Frequency in Patients

Optimized Assessment of qPCR-Based Vector Copy Numbers as a Safety Parameter for GMP-Grade CAR T Cells and Monitoring of Frequency in Patients

Chimeric antigen receptor (CAR) T cells are considered genetically modified organisms (GMOs) and constitute gene therapy medicinal products. Thus, CAR T cell manufacturing for clinical application is strictly regulated. Appropriate methods to assess vector copy numbers (VCNs) in CAR T cell products...

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Bibliographic Details
Main Authors: Alexander Kunz, Ulrike Gern, Anita Schmitt, Brigitte Neuber, Lei Wang, Angela Hückelhoven-Krauss, Birgit Michels, Susanne Hofmann, Carsten Müller-Tidow, Peter Dreger, Michael Schmitt, Maria-Luisa Schubert
Format: Article
Language:English
Published: Elsevier 2020-06-01
Series:Molecular Therapy: Methods & Clinical Development
Subjects:
vector copy number
single-copy gene
CAR T cells
qPCR
CAR T cell monitoring
Online Access:http://www.sciencedirect.com/science/article/pii/S2329050120300280

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