Comparability exercise of critical quality attributes of clinical-grade human mesenchymal stromal cells from the Wharton's jelly : Single-use stirred tank bioreactors versus planar culture systems
López-Fernández, Alba (Vall d'Hebron Institut de Recerca (VHIR))
Codinach, Margarita (Universitat Autònoma de Barcelona. Banc de Sang i Teixits)
Coca, María Isabel (Universitat Autònoma de Barcelona. Banc de Sang i Teixits)
Prat-Vidal, Cristina (Universitat Autònoma de Barcelona. Banc de Sang i Teixits)
Castaño Cardoso, Julio (Universitat Autònoma de Barcelona. Banc de Sang i Teixits)
Torrents, Sílvia (Universitat Autònoma de Barcelona. Banc de Sang i Teixits)
Aran, Gemma (Universitat Autònoma de Barcelona. Banc de Sang i Teixits)
Rodríguez, Luciano (Universitat Autònoma de Barcelona. Banc de Sang i Teixits)
Querol, Sergi (Universitat Autònoma de Barcelona. Banc de Sang i Teixits)
Vives Armengol, Joaquim (Universitat Autònoma de Barcelona. Departament de Medicina)

Date:	2024
Description:	9 pàg.
Abstract:	Background aims The increasing demand of clinical-grade mesenchymal stromal cells (MSCs) for use in advanced therapy medicinal products (ATMPs) require a re-evaluation of manufacturing strategies, ensuring scalability from two-dimensional (2D) surfaces to volumetric (3D) productivities. Herein we describe the design and validation of a Good Manufacturing Practice-compliant 3D culture methodology using microcarriers and 3-L single-use stirred tank bioreactors (STRs) for the expansion of Wharton's jelly (WJ)-derived MSCs in accordance to current regulatory and quality requirements. Methods MSC,WJ were successfully expanded in 3D and final product characterization was in conformity with Critical Quality Attributes and product specifications previously established for 2D expansion conditions. Results After 6 days of culture, cell yields in the final product from the 3D cultures (mean 9. 48 × 108 ± 1. 07 × 107 cells) were slightly lower but comparable with those obtained from 2D surfaces (mean 9. 73 × 108 ± 2. 36 × 108 cells) after 8 days. In all analyzed batches, viability was.
Note:	Altres ajuts: acords transformatius de la UAB
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Good Manufacturing Practice ; Advanced therapy medicinal product ; Bioprocessing ; Comparability exercise ; Microcarriers ; Single-use stirred tank bioreactor ; Umbilical cord mesenchymal stromal cell ; SDG 3 - Good Health and Well-being
Published in:	Cytotherapy, Vol. 26, Num. 5 (may 2024) , p. 418-426, ISSN 1477-2566

DOI: 10.1016/j.jcyt.2023.08.008
PMID: 37715777

9 p, 1.7 MB

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