Transduction efficiency (TE) is a key measure of CAR T cell manufacturing quality; however, its variability and relationship to the final product phenotype remain incompletely understood. In this retrospective study, we evaluated TE across 204 GMP-manufactured CAR T cell products, integrating manufacturing parameters,...
L. Shao, M. Procházková, Yi-Hua Cai et al.· Molecular therapy. Advances· 0 citations
A Quality-by-Design (QbD) framework is proposed-a systematic, science- and risk-based development approach that begins with predefined product objectives and links critical quality attributes to material attributes and process controls and discusses development pathways that emphasize platform–indication matching, inna...
David F. Stroncek, Jia-Qiang Ren, Anh Dinh· Translational Insights· 0 citations
Compared to the standard 7-day method, the 3-day approach resulted in expression of genes associated with a more stem-like phenotype while reducing manufacturing time and cost, and may provide a practical alternative for decentralized CAR T-cell manufacturing, particularly in resource-limited settings.
Isabella Vignola, M. Procházková, L. Shao et al.· Journal of Translational Med...· 1 citation
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