Optimisation of a potency assay for the assessment of immunomodulative potential of clinical grade multipotent mesenchymal stromal cells
Por:
Oliver-Vila, I, Ramirez-Moncayo, C, Grau-Vorster, M, Marin-Gallen, S, Caminal, M, Vives, J
Publicada:
1 feb 2018
Resumen:
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.
Filiaciones:
Oliver-Vila, I:
Banc Sang & Teixits, Serv Terapia Cel Lular, Edifici Dr Frederic Duran i Jorda, Barcelona 08005, Spain
Ramirez-Moncayo, C:
Banc Sang & Teixits, Serv Terapia Cel Lular, Edifici Dr Frederic Duran i Jorda, Barcelona 08005, Spain
Grau-Vorster, M:
Banc Sang & Teixits, Serv Terapia Cel Lular, Edifici Dr Frederic Duran i Jorda, Barcelona 08005, Spain
Marin-Gallen, S:
Banc Sang & Teixits, Serv Terapia Cel Lular, Edifici Dr Frederic Duran i Jorda, Barcelona 08005, Spain
Caminal, M:
Banc Sang & Teixits, Serv Terapia Cel Lular, Edifici Dr Frederic Duran i Jorda, Barcelona 08005, Spain
Vives, J:
Banc Sang & Teixits, Serv Terapia Cel Lular, Edifici Dr Frederic Duran i Jorda, Barcelona 08005, Spain
Univ Autonoma Barcelona, Dept Med, Passeig Vall dHebron 129-139, Barcelona 08035, Spain
Univ Autonoma Barcelona, Musculoskeletal Tissue Engn Grp, Vall DHebron Res Inst VHIR, Passeig Vall dHebron 129-139, Barcelona 08035, Spain
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