Fiche publication
Date publication
décembre 2025
Journal
Bone marrow transplantation
Auteurs
Membres identifiés du Cancéropôle Est :
Pr BENSOUSSAN Danièle
,
Dr FERRAND Christophe
,
Dr DESCHAMPS Marina
,
Dr GALAINE Jeanne
,
Dr REPPEL Loïc
Tous les auteurs :
Chartral U, Galaine J, Giverne C, Auxenfans C, Reppel L, Marton C, Thiant S, Clémenceau B, Derenne S, Sabatier F, Veran J, Moisan A, Rouard H, Tertrais K, Dachy G, Demerle C, Calmels B, Chabannon C, Forcade E, Viel S, Bensoussan D, de Vos J, Galy A, De Oliveira C, Boucher H, Magrin E, Fabreguettes JR, Cavazzana M, Larghero J, Deschamps M, Martinet J, Boyer O, Ferrand C, Yakoub-Agha I, Diana JS
Lien Pubmed
Résumé
Academic autologous cell manufacturing offers key advantages, including cost-effectiveness, accessibility, and flexibility. However, the management of Raw Materials, Reagents, and Consumables (RMRCs) is essential for ensuring product purity, safety, and effectiveness. Variations in RMRC quality can increase production costs and result in batch failures. This work from the GMP-Bioproduction group of the French Consortium in Advancing Cancer Cell and Gene Therapy (UNITC) outlines a multicenter study conducted from 2022 to 2024 across all 11 French academic cell and gene therapy facilities producing Advanced Therapy Medicinal Products, evaluating current RMRC management practices. The study highlights significant challenges, including supply shortages, reference changes, and inconsistent quality controls. While RMRC-related non-conformities accounted for only 6.8% of total issues, they frequently required complex procedural adjustments, resulting in added financial and operational burdens. Despite differences in production scale and ATMP types, all centers consistently evaluated the criticality of RMRC, reflecting strong alignment in risk assessment practices. To address these issues, the study proposes recommendations, including a unified RMRC risk classification system, harmonized quality assurance processes. These actions aim to strengthen regulatory compliance, enhance collaboration across academic centers, and improve the overall resilience of academic decentralized CAR-T cells manufacturing in France.
Référence
Bone Marrow Transplant. 2025 12 11;:
