The TIBA assay will ensure sufficient sensitivity to detect any shifts in potency of the commercial product that could arise during changes in manufacturing processes or production in new facilities. This assay will be used as part of a matrix to release each commercial batch of RYONCIL in conjunction with the existing potency assays which determine IL-2Rα inhibition and CAP (Cell Adhesion and Proliferation), as per the product's Biologics License. Together these assays ensure that the RYONCIL product is consistent, potent, and clinically effective.

RYONCIL is the first industrially-manufactured allogeneic MSC product approved by FDA for any indication, and the only MSC product to be approved for patients with steroid-refractory acute graft versus host disease (SR-aGvHD) aged 2 months or older.1 Mesoblast and FDA have been working closely together since RYONCIL was approved for commercial use to ensure alignment on continued advancements to the product’s manufacturing processes and implementation of assays measuring the product’s ongoing quality control.

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