Stability enhancement of clinical grade multipotent mesenchymal stromal cell-based products
Mirabel, Clémentine (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Puente-Massaguer, Eduard (Universitat Autònoma de Barcelona. Departament d'Enginyeria Química, Biològica i Ambiental)
del Mazo-Barbara, Anna (Banc de Sang i Teixits. Servei de Teràpia Cel·lular)
Reyes, Blanca (Banc de Sang i Teixits. Servei de Teràpia Cel·lular)
Morton, Philip (Albumedix Ltd (Nottingham))
Gòdia, Francesc (Universitat Autònoma de Barcelona. Departament d'Enginyeria Química, Biològica i Ambiental)
Vives Armengol, Joaquim (Universitat Autònoma de Barcelona. Departament de Medicina)

Data:	2018
Resum:	Successful delivery of cell-based therapeutics into patients is compromised by their short shelf-life upon release from production facilities due to the living nature of the active component that rapidly loses viability, and therefore its properties. In this context, the use of appropriate additives may contribute to the stabilisation of the cellular component within specifications for a longer time until administration. In the present study, we evaluated the effect of different formulations on the stability of viability, identity, and potency of clinical grade multipotent mesenchymal stromal cells in suspension, both electrolyte solution and protein content were found to impact on their shelf-life. Particularly cryopreservation of cells in a Plasmalyte 148 supplemented with 2% (w/v) AlbIX (a yeast-derived recombinant albumin) and 10% (v/v) dimethyl sulfoxide, and final formulation post-thawing in Plasmalyte 148 supplemented with 2% (w/v) AlbIX enabling prolonged stability from 24 h up to 72 h in optimal conditions. Further investigation on the mechanisms of action involved revealed a delay of apoptosis progression into late stage when AlbIX was present. The use of optimal formulations for each cell type of interest is crucial to extend the shelf life of cell-based pharmaceuticals and contribute to solve logistical challenges. We demonstrated that the use of Plasmalyte 148 supplemented with 2% (w/v) AlbIX resulted in superior stability of multipotent mesenchymal stromal cells without affecting their identity and multipotency. The online version of this article (10. 1186/s12967-018-1659-4) contains supplementary material, which is available to authorized users.
Ajuts:	Agència de Gestió d'Ajuts Universitaris i de Recerca 2017SGR898 Agència de Gestió d'Ajuts Universitaris i de Recerca 2017SGR719 Instituto de Salud Carlos III RD16/0011/0028
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Multipotent mesenchymal stromal cell ; Potency assay ; Cellular therapy ; Cell culture ; Logistics ; Apoptosis ; Stability assessment ; Quality compliance
Publicat a:	Journal of translational medicine, Vol. 16 (october 2018) , ISSN 1479-5876

DOI: 10.1186/s12967-018-1659-4
PMID: 30355298

10 p, 5.7 MB

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