Optimizing CAR-T treatment : A T2EVOLVE guide to raw and starting material selection
Navarro Velázquez, Sergio (Hospital Clínic i Provincial de Barcelona)
Moukheiber, C. (Institut de Recherches Internationales Servier)
Inogés Sancho, S. (Clínica Universidad de Navarra)
Ruiz Guillén, M. (Clínica Universidad de Navarra)
López-Díaz de Cerio, A. (Clínica Universidad de Navarra)
Sanges, C. (Universitätsklinikum Würzburg)
Tanaka, T. (Astellas Pharma Inc)
Arnould, S. (Institut de Recherches Internationales Servier)
Briones Meijide, Javier (Institut de Recerca Sant Pau)
Dolstra, H. (Radboud University Medical Center)
Hudecek, M. (Fraunhofer Institute for Cell Therapy and Immunology)
Choudhary, R. (Takeda Development Centers Americas. Inc)
Schapitz, I. (Bayer Vital GmbH)
Juan, Manel (Hospital Clínic i Provincial de Barcelona)
Worel, N. (Medical University of Vienna)
Ammar, D. (Astellas Pharma B.V.)
Luu, M. (Universitätsklinikum Würzburg)
Müller, M. (Fraunhofer Institute for Cell Therapy and Immunology)
Schroeder, B. (Miltenyi Biotec B.V. & Co KG)
Negre, H. (Institut de Recherches Internationales Servier)
Franz, P. (Fraunhofer Institute for Cell Therapy and Immunology)
Universitat Autònoma de Barcelona

Data:	2025
Resum:	Chimeric antigen receptor (CAR)-T cell products, classified as Advanced Therapy Medicinal Products (ATMPs), have shown promising outcomes in cancer immunotherapy. The quality of raw and starting materials used in manufacturing is critical to ensure the efficacy and safety of CAR-T cell products and depends primarily on the selection of the right materials and the right suppliers. It is essential to consider a long-term strategy when selecting raw and starting materials to prevent delays in the supply of innovative, high-quality, and safe therapies to patients. A thorough assessment will allow developers not only to select suppliers who comply with regulatory requirements but also to ensure a sustainable supply of materials throughout the development and the commercial phases. A careful selection of materials and suppliers can avoid the need of comparability studies due to changes in the supply of materials, impacting costs and causing significant delays in development and treatment readiness for patients. This work, coordinated by the TEVOLVE IMI consortium, provides guidance for the selection and handling of raw and starting materials. By following these suggestions, developers can ensure that they use high quality raw and starting materials through the product development and life cycle, resulting in safe and effective CAR-T therapies for patients.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article de revisió ; recerca ; Versió publicada
Matèria:	CAR-T cells ; GMP ; Clinical trials ; Comparability ; Quality ; Raw material ; Stability ; Starting material ; Supplier selection ; Viral safety
Publicat a:	Molecular Therapy, Vol. 33 Núm. 3 (may 2025) , p. 847-865, ISSN 1525-0024

DOI: 10.1016/j.ymthe.2024.11.017
PMID: 39533710

19 p, 2.2 MB

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