Off-the-Shelf Allogeneic Mesenchymal Stromal Cell Products: Potency Assays and Batch Consistency
DOI:
https://doi.org/10.5281/zenodo.22274838Keywords:
Mesenchymal stromal cells; Potency assay; Batch consistency; Allogeneic cell therapy; Donor variabilityAbstract
Background: Off-the-shelf allogeneic mesenchymal stromal cell products must be released lot by lot against a specification
anchored by a potency assay, and many candidate assays exist.
Objective: To ask whether any candidate potency assay has been shown to predict clinical response, and what follows for batch
consistency.
Methods: Narrative review of potency assay studies, regulatory guidance and approval records for licensed products.
Findings: No assay reviewed has been shown to correlate with clinical response. In a ten-donor panel, interferon-gamma-induced
IDO1 expression ranged from 12% to 91% of cells among preparations meeting identity criteria, and correlated with T-cell
proliferation at r = -0.9. Reviewers of the first licensed product recorded that its release assays may not support comparability
across manufacturing changes.
Conclusions: The evidence supports demonstrating batch consistency against a specification; it does not support any claim that a
release value predicts patient benefit, which requires lot-linked outcome data.
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