Securing raw materials, reagents, and consumable supplies in the academic bioproduction UNITC network: because the chain is only as strong as its weakest link

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

doi:10.1038/s41409-025-02756-2

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Securing raw materials, reagents, and consumable supplies in the academic bioproduction UNITC network: because the chain is only as strong as its weakest link

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Securing raw materials, reagents, and consumable supplies in the academic bioproduction UNITC network: because the chain is only as strong as its weakest link

Ugo Chartral, Jeanne Galaine, Camille Giverne, Céline Auxenfans, Loic Reppel, Chrystel Marton, Stéphanie Thiant, Béatrice Clémenceau, Sophie Derenne, Florence Sabatier, …

Bone marrow transplantation (Basingstoke)

11/12/2025

DOI: https://doi.org/10.1038/s41409-025-02756-2

PMID: 41381878

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.

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Titre: Securing raw materials, reagents, and consumable supplies in the academic bioproduction UNITC network: because the chain is only as strong as its weakest link
Créateurs - sans rôle: Ugo Chartral - University Paris Cité, Paris, France
Jeanne Galaine - Université de Franche-Comté, EFS, INSERM, UMR RIGHT, Besançon, France
Camille Giverne - CHU de Rouen, Laboratoire d'Immunologie et de Biothérapies, Université de Rouen Normandie, INSERM, Rouen, France
Céline Auxenfans - Plateforme ARTEMIS, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France
Loic Reppel - Centre Hospitalier Régional et Universitaire de Nancy
Chrystel Marton - Université de Lille
Stéphanie Thiant - Division of hematology, Oncology, and transplantation, department of medicine, Maisonneuve-Rosemont hospital, Montréal, Québec, Canada
Béatrice Clémenceau - Unité de Thérapie Cellulaire et Génique (UTCG), CHU de Nantes, Nantes, France
Sophie Derenne - EFS, La Plaine Saint Denis, France
Florence Sabatier - Laboratoire de Culture et Thérapie cellulaire (LCTC) & module Biothérapies du Centre d'Investigations Cliniques de Marseille, INSERM CBT-1409 / Aix-Marseille Université/AP-HM, Marseille, France
Julie Veran - Laboratoire de Culture et Thérapie cellulaire (LCTC) & module Biothérapies du Centre d'Investigations Cliniques de Marseille, INSERM CBT-1409 / Aix-Marseille Université/AP-HM, Marseille, France
Anaick Moisan - Cell Therapy and Engineering Unit, EFS Rhône Alpes, Saint Ismier, France
Hélène Rouard - EFS Ile-de-France, Ivry-sur-Seine, France
Karine Tertrais - EFS Centre Pays de la Loire, Saint-Herblain, France
Guillaume Dachy - Hematology department, Cliniques Universitaires Saint-Luc, Brussels, Belgium
Clemence Demerle - Centre de Thérapie Cellulaire, Institut Paoli-Calmettes (IPC) & module Biothérapies du Centre d'Investigations Cliniques de Marseille, INSERM CBT-1409 / Aix-Marseille Université / AP-HM /IPC, Marseille, France
Boris Calmels - Centre de Thérapie Cellulaire, Institut Paoli-Calmettes (IPC) & module Biothérapies du Centre d'Investigations Cliniques de Marseille, INSERM CBT-1409 / Aix-Marseille Université / AP-HM /IPC, Marseille, France
Christian Chabannon - Centre de Thérapie Cellulaire, Institut Paoli-Calmettes (IPC) & module Biothérapies du Centre d'Investigations Cliniques de Marseille, INSERM CBT-1409 / Aix-Marseille Université / AP-HM /IPC, Marseille, France
Edouard Forcade - CHU de Bordeaux, Service Hématologie Clinique et Thérapie Cellulaire, CNRS UMR 5164, Bordeaux, France
Sebastien Viel - Plateforme ARTEMIS, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France
Daniele Bensoussan - Centre Hospitalier Régional et Universitaire de Nancy
John de Vos - Department of Cell and Tissue Engineering, University Montpellier, CHU Montpellier, Montpellier, France
Anne Galy - ART-TG, INSERM, US35, Corbeil-Essonnes, France
Caroline De Oliveira - AP-HP, Université Paris Cité, Hôpital Saint-Louis, Centre MEARY de Thérapie Cellulaire et Génique, Unité de Thérapie Cellulaire, Centre d'Investigation Clinique en Biothérapies, INSERM, Paris, France
Hélène Boucher - AP-HP, Université Paris Cité, Hôpital Saint-Louis, Centre MEARY de Thérapie Cellulaire et Génique, Unité de Thérapie Cellulaire, Centre d'Investigation Clinique en Biothérapies, INSERM, Paris, France
Elisa Magrin - APHP, Hôpital Universitaire Necker Enfants Malades, Centre d'Investigation Clinique en Biothérapie, CIC BT 1416, Laboratoire de Thérapie Cellulaire et Génique, Paris, France
Jean-Roch Fabreguettes - AP-HP, Université Paris Cité, Hôpital Saint-Louis, Centre MEARY de Thérapie Cellulaire et Génique, Unité de Thérapie Cellulaire, Centre d'Investigation Clinique en Biothérapies, INSERM, Paris, France
Marina Cavazzana - University Paris Cité, Paris, France
Jérome Larghero - AP-HP, Université Paris Cité, Hôpital Saint-Louis, Centre MEARY de Thérapie Cellulaire et Génique, Unité de Thérapie Cellulaire, Centre d'Investigation Clinique en Biothérapies, INSERM, Paris, France
Marina Deschamps - Université de Franche-Comté, EFS, INSERM, UMR RIGHT, Besançon, France
Jérémie Martinet - Université de Rouen Normandie
Olivier Boyer - CHU de Rouen, Laboratoire d'Immunologie et de Biothérapies, Université de Rouen Normandie, INSERM, Rouen, France
Christophe Ferrand - Université de Franche-Comté, EFS, INSERM, UMR RIGHT, Besançon, France
Ibrahim Yakoub-Agha - CHU Lille, Univ. Lille, INSERM, U1286-INFINITE-Institute for Translational Research in Inflammation, Lille, France
Jean-Sebastien Diana - University Paris Cité, Paris, France. Jean-sebastien.diana@aphp.fr
Détails de publication: Bone marrow transplantation (Basingstoke)
Identifiants: 99141227609311
Unité académique: Cell souches plasticité cellul régénérat tissulaire immuno des maladies inflamm - IRMB
Langue: English
Type de ressource: Journal article