Establishing a GMP-compliant manufacturing process and phase-appropriate analytics for early development of a FiCAR T-cell product with a novel CAR spacer

Establishing a GMP-compliant manufacturing process and phase-appropriate analytics for early development of a FiCAR T-cell product with a novel CAR spacer

Abstract There is a growing demand for chimeric antigen receptor (CAR) -T cells for clinical trials. Consequently, new centers capable of manufacturing advanced therapy medicinal products (ATMPs) are needed. In this study, we established a good manufacturing practice -compliant manufacturing process...

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Main Authors: Annu Luostarinen, Arja Vuorela, Erja Kerkelä, Mimmi Patrikoski, Annika Kotovuori, Jan Koski, Jonna Ahoniemi, Kaarina Lähteenmäki, Jenni Lehtisalo, Terhi Oja, Henrik Paavilainen, Anu Autio, Marie Nyman, Veera Nikoskelainen, Virginie Kergourlay, Endrit Elbasani, Bert van Veen, Anil Thotakura, Hector Monzo, Päivi M. Ojala, Matti Korhonen, Heidi Hongisto, Anita Laitinen
Format: Article
Language:English
Published: Nature Portfolio 2025-03-01
Series:Scientific Reports
Subjects:
CAR T-cell
ATMP
Early development
Manufacturing
Analytical testing
Online Access:https://doi.org/10.1038/s41598-025-92736-9
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