Harmonisation of quality control tests for academic production of CAR-T cells: a position paper from the WP-bioproduction of the UNITC consortium
This position paper from the Bioproduction Working Group of the UNITC Consortium seeks to harmonize quality control (QC) procedures for academic production of autologous CAR-T cells. The primary objective is to standardize QC testing for batch release in academic cell therapy units. Academic CAR-T manufacturing under the hospital exemption pathway enables faster, more cost-effective production and the use of fresh cells, eliminating the need for cryopreservation. Standardized QC processes are critical to ensure consistent product quality and safety. This paper focuses on key QC measures, including mycoplasma detection using validated commercial kits or in-house methods with on-site validation, endotoxin testing via Limulus Amebocyte Lysate (LAL) or Recombinant Factor C (rFC) assays with validated protocols to prevent matrix interference, vector copy number (VCN) quantification through validated qPCR or ddPCR techniques, and potency assessment through IFN-γ ELISA following antigenic stimulation. Emphasizing method validation and standardized testing, this work underscores the importance of robust QC strategies to ensure the safety and efficacy of CAR-T cell therapies, with ongoing efforts dedicated to optimizing these processes. This workshop focuses on addressing the harmonization of some quality control (QC) measures required for the validation of academic CAR-T cell production :mycoplasma detection; endotoxin testing; vector copy number (VCN) quantification; potency testing and the use of surrogate markers, if applicable. Sterility testing and characterization/identity/purity assessments are not covered in this work.
Authors
- Stéphanie Thiant (ORCID: https://orcid.org/0009-0002-7950-9354)
- Guillaume Dachy (ORCID: https://orcid.org/0000-0002-1668-975X)
- Anne Galy (ORCID: https://orcid.org/0000-0002-0153-4392)
- Jean‐Baptiste Latouche (ORCID: https://orcid.org/0000-0003-4802-5429)
- Sophie Derenne
- Marina Deschamps (ORCID: https://orcid.org/0000-0002-0564-0926)
- Chrystel Marton (ORCID: https://orcid.org/0000-0003-4237-4652)
- Ulrike Koehl (ORCID: https://orcid.org/0000-0002-8159-9160)
- Olivier Boyer (ORCID: https://orcid.org/0000-0002-7591-307X)
- Ibrahim Yakoub‐Agha (ORCID: https://orcid.org/0000-0003-4524-8782)
- Danièle Bensoussan (ORCID: https://orcid.org/0000-0002-1706-1761)
- Jeanne Galaine (ORCID: https://orcid.org/0000-0001-7592-6447)
- Jean‐Sébastien Diana (ORCID: https://orcid.org/0000-0001-8806-011X)
- Christian Chabannon (ORCID: https://orcid.org/0000-0002-3755-4889)
- Sébastien Viel (ORCID: https://orcid.org/0000-0002-5085-443X)
- Aurore Dougé (ORCID: https://orcid.org/0000-0001-7737-3735)
- John De Vos (ORCID: https://orcid.org/0000-0003-1880-4130)
- Jérôme Larghero (ORCID: https://orcid.org/0000-0003-2086-7448)
- Camille Giverne
- Christophe Ferrand (ORCID: https://orcid.org/0000-0003-0119-3919)
- Loïc Reppel (ORCID: https://orcid.org/0000-0001-7951-6293)
- Halvard Bönig (ORCID: https://orcid.org/0000-0003-0088-2675)
- Béatrice Clemenceau (ORCID: https://orcid.org/0000-0001-5305-4502)
- J. Martinet
- Édouard Forcade (ORCID: https://orcid.org/0000-0002-8873-2868)
- Clémence Demerle
- Ludovic Lemée
Institutions
- Goethe University Frankfurt (DE)
- Hôpital Necker-Enfants Malades (FR)
- Cliniques Universitaires Saint-Luc (BE)
- Inserm (FR)
- Université Clermont Auvergne (FR)
- Université Paris Cité (FR)
- Aix-Marseille Université (FR)
- Université de Lille (FR)
- Hôpital Maisonneuve-Rosemont (CA)
- Centre Hospitalier Universitaire de Bordeaux (FR)
- Centre Hospitalier Universitaire de Lille (FR)
- Centre Hospitalier Universitaire de Nantes (FR)
- Centre Hospitalier Universitaire de Montpellier (FR)
- Assistance Publique – Hôpitaux de Paris (FR)
- Hospices Civils de Lyon (FR)
- Hôpital Edouard Herriot (FR)
- Lille Inflammation Research International Center (FR)
- Établissement Français du Sang (FR)
- Centre de Recherche en Cancérologie de Marseille (FR)
- Hôpital Saint-Louis (FR)
- Fraunhofer Institute for Cell Therapy and Immunology (DE)
- Ingénierie Moléculaire et Physiopathologie Articulaire (FR)
- Centre Hospitalier Universitaire de Rouen (FR)
- Université de Rouen Normandie (FR)
- Université de Lorraine (FR)
- Université de Franche-Comté (FR)
Publication Details
- Journal
- Bone Marrow Transplantation
- Published
- 2025-05-29
- DOI
- https://doi.org/10.1038/s41409-025-02637-8
- Citations
- 4
- Primary Topic
- CAR-T cell therapy research
- Type
- article
- Field-Weighted Citation Impact
- 4.18
Funders
- Centre hospitalier régional universitaire de Lille