Optimized GMP-grade production of non-viral Sleeping Beauty-generated CARCIK cells for enhanced fitness and clinical scalability

Optimized GMP-grade production of non-viral Sleeping Beauty-generated CARCIK cells for enhanced fitness and clinical scalability

Abstract Background Strict adherence to GMP guidelines and regulatory compliance is crucial when transitioning from research to clinical-grade production of ATMPs like CAR T cells. The success of CAR T cell therapy in treating hematological malignancies highlights the need for closed or automated sy...

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Main Authors: Ilaria Pisani, Giusi Melita, Patricia Borges de Souza, Stefania Galimberti, Angela Maria Savino, Jolanda Sarno, Beatrice Landoni, Stefano Crippa, Elisa Gotti, Carolina Cuofano, Olga Pedrini, Chiara Capelli, Giada Matera, Daniela Belotti, Stefania Cesana, Benedetta Cabiati, Michele Quaroni, Valentina Colombo, Massimiliano Mazza, Barbara Vergani, Anna Gaimari, Fabio Nicolini, Marcella Tazzari, Martine Bocchini, Marta Serafini, Alessandro Rambaldi, Benedetta Rambaldi, Giuseppe Dastoli, Andrea Biondi, Giuseppe Gaipa, Martino Introna, Josée Golay, Sarah Tettamanti
Format: Article
Language:English
Published: BMC 2025-05-01
Series:Journal of Translational Medicine
Subjects:
Good manufacturing practices (GMP)
CAR T cells
Hematological malignancies
Sleeping beauty transposon
Workflow optimization
T cell fitness
Online Access:https://doi.org/10.1186/s12967-025-06416-3
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