Securing raw materials, reagents, and consumable supplies in the academic bioproduction UNITC network: because the chain is only as strong as its weakest link.
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.
DOI: 10.1038/s41409-025-02756-2, PMID: 41381878
Authors: Ugo Chartral, Jeanne Galaine, Camille Giverne, Céline Auxenfans, Loic Reppel, Chrystel Marton, Stéphanie Thiant, Béatrice Clémenceau, Sophie Derenne, Florence Sabatier, Julie Veran, Anaick Moisan, Hélène Rouard, Karine Tertrais, Guillaume Dachy, Clemence Demerle, Boris Calmels, Christian Chabannon, Edouard Forcade, Sebastien Viel, Daniele Bensoussan, John de Vos, Anne Galy, Caroline De Oliveira, Hélène Boucher, Elisa Magrin, Jean-Roch Fabreguettes, Marina Cavazzana, Jérome Larghero, Marina Deschamps, Jérémie Martinet, Olivier Boyer, Christophe Ferrand, Ibrahim Yakoub-Agha, Jean-Sebastien Diana
