Optimisation of a potency assay for the assessment of immunomodulative potential of clinical grade multipotent mesenchymal stromal cells

Irene Oliver-Vila, Carmen Ramírez-Moncayo, Marta Grau-Vorster, Sílvia Marín-Gallén, Marta Caminal, Joaquim Vives

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    9 Citations (Scopus)

    Abstract

    © 2018, Springer Science+Business Media B.V., part of Springer Nature. Clinical use of multipotent Mesenchymal Stromal Cell (MSC)-based medicinal products requires their production in compliance with Good Manufacturing Practices, thus ensuring that the final drug product meets specifications consistently from batch to batch in terms of cell viability, identity, purity and potency. Potency relates to the efficacy of the medicine in its target clinical indication, so adequate release tests need to be defined and validated as quality controls. Herein we report the design and optimisation of parameters affecting the performance of an in vitro cell-based assay for assessing immunomodulatory potential of clinical grade MSC for human use, based on their capacity to inhibit proliferation of T lymphocytes under strong polyclonal stimuli. The resulting method was demonstrated to be reproducible and relatively simple to execute. Two case studies using clinical grade MSC are presented as examples to illustrate the applicability of the methodology described in this work.
    Original languageEnglish
    Pages (from-to)31-44
    JournalCytotechnology
    Volume70
    Issue number1
    DOIs
    Publication statusPublished - 1 Feb 2018

    Keywords

    • Cell culture
    • Cell-based assay
    • Cellular therapy
    • Co-culture
    • Immunomodulative potential
    • Lymphocyte
    • Multipotent Mesenchymal Stromal Cell
    • Potency assay

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  • Cite this

    Oliver-Vila, I., Ramírez-Moncayo, C., Grau-Vorster, M., Marín-Gallén, S., Caminal, M., & Vives, J. (2018). Optimisation of a potency assay for the assessment of immunomodulative potential of clinical grade multipotent mesenchymal stromal cells. Cytotechnology, 70(1), 31-44. https://doi.org/10.1007/s10616-017-0186-0