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In a retrospective multivariate analysis of our 368 manufactured CAR-T cell batches (tisagenlecleucel), we investigated potential factors that might be associated with manufacturing failure. In this letter to the editor, we provide a summary of our findings and outline recommendations for future advanced quality control strategies.<\/jats:p>","DOI":"10.1177\/10430342261472597","type":"journal-article","created":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T07:42:06Z","timestamp":1787211726000},"page":"802-804","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Real-World Data from a Single-Center, Large Academic Centralized Manufacturing of CD19 CAR T Cells in an Industry Partnership"],"prefix":"10.1177","volume":"37","author":[{"given":"Kati","family":"Kebbel","sequence":"first","affiliation":[{"name":"Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerno","family":"Schmiedeknecht","sequence":"additional","affiliation":[{"name":"Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Quaiser","sequence":"additional","affiliation":[{"name":"Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susann","family":"Schumann","sequence":"additional","affiliation":[{"name":"Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolin","family":"Poch","sequence":"additional","affiliation":[{"name":"Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuela","family":"Ha\u00df","sequence":"additional","affiliation":[{"name":"Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Grahnert","sequence":"additional","affiliation":[{"name":"Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margarida","family":"Rodrigues","sequence":"additional","affiliation":[{"name":"Novartis Farma\u2014Produtos Farmac\u00eauticos S.A., Lisboa, Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristin","family":"Reiche","sequence":"additional","affiliation":[{"name":"Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Germany"},{"name":"Institute of Clinical Immunology, University of Leipzig, Leipzig, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markus","family":"Kreuz","sequence":"additional","affiliation":[{"name":"Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8159-9160","authenticated-orcid":false,"given":"Ulrike","family":"Koehl","sequence":"additional","affiliation":[{"name":"Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Germany"},{"name":"Institute of Clinical Immunology, University of Leipzig, Leipzig, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,8,12]]},"reference":[{"key":"e_1_3_2_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.omtm.2019.11.018"},{"key":"e_1_3_2_3_1","first-page":"331","article-title":"Manufacturing results of tisagenlecleucel for acute lymphoblastic leukemia: A survey by the CAR-T cell therapy taskforce of the Japan Society of Transfusion Medicine and Cell Therapy","volume":"64","author":"Jo T","year":"2023","unstructured":"2.Jo T, , Henzan T, , Tomizawa D, et al. 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