Health AI Central
Peer-Reviewed Publication
Cytotherapy2026;28(11):102939.November 1, 2026Journal Article

Overcoming access barriers in European CAR-T therapy: the role of decentralized manufacturing and the EASYGEN framework.

Dominik Griebling1, Anna Rebecca Scheiwe2, Ralf Kuhlen2, Chloé Zech2, Pia Müller2, Christian Rische2, Vivian Längst2, Chris Wegener3, Lexie Schmidt3, Paige Bothwell3, Kyle Thompson3, Katrin Mestermann4, Carmen Sanges4, David Krones4, Mirko Müller4, Anna Dünkel4, Michael Hudecek4, Ulrike Köhl4, Ayal Hendel5, Dmitry Kashanin6, Vivienne Williams6, Julia Schüler7, Natacha Bolaños8, Louise McNamara8, Tuula Rintala8, Anna Sureda8, Afschin Gandjour9, Theresa D Ahrens10, Patrick Mennig10, Eduard Christiaan Groen10, Bertram Glass11, Agnes Vosen12, Julia Busch-Casler12, Marija Radic12, Anika Teichert12, Ralf Hoffmann13, Thomas Brzoska14, Catrina Pietralla15, Jens O Brunner15, Theresa Kagerbauer16, Christin Zündorf16, George S Baillie17, Nattaporn Phanthaphol17, Felipe Prósper18, Juan R Rodriguez Madoz19, Cristina Carames20, Sonja Steppan2
1Fresenius SE & Co. KGaA, Bad Homburg, Germany. Electronic address: Dominik.Griebling@fresenius.com.
2Fresenius SE & Co. KGaA, Bad Homburg, Germany.
3Fresenius Kabi, Lake Zurich, Illinois 60047, USA.
4Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig, Germany.
5Institute of Nanotechnology and Advanced Materials, The Mina and Everard Goodman Faculty of Life Sciences, Bar-Ilan University, Safed, Israel.
6Cellix Limited, Dublin, Ireland.
7Charles River Laboratories Germany GmbH, Freiburg, Germany.
8European Society for Blood and Marrow Transplantation, Barcelona, Spain.
9Frankfurt School of Finance & Management, Germany.
10Fraunhofer Institute for Experimental Software Engineering IESE, Kaiserslautern, Germany.
11Helios Hospital Berlin-Buch GmbH, Berlin, Germany.
12Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Dresden, Germany.
13Philips Intellectual Property & Standards, Eindhoven, The Netherlands.
14Pro-Liance Global Solutions GmbH, Münster, Germany.
15Technical University of Denmark (DTU), Kongens Lyngby, Copenhagen, Denmark.
16TQ Therapeutics GmbH, Munich, Germany.
17School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK.
18Hematology and Cell Therapy Department, Clinica Universidad de Navarra, Cancer Center Clinica Universidad de Navarra (CCUN), Centro de Investigacion Biomedica en Red de Cancer (CIBERONC), 31009, Pamplona, Spain.
19Hemato-Oncology Program, Cima Universidad de Navarra, Cancer Center Clinica Universidad de Navarra (CCUN), Centro de Investigacion Biomedica en Red de Cancer (CIBERONC), IdiSNA, Pamplona, Spain.
20Quirónsalud Healthcare Network, Madrid, Spain.
PubMed DOI

Abstract

BACKGROUND: Chimeric antigen receptor T-cell (CAR-T) therapies have revolutionized the treatment of refractory B-cell malignancies, with seven approved therapies in major jurisdictions and rapid label expansion toward earlier lines of treatment. Nevertheless, patient access remains limited by multiple bottlenecks, including shortages of lentiviral vectors, manufacturing capacity constraints, and e…

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