Mesoblast Receives FDA Approval To Implement A New Potency Assay, T-Cell Proliferation Inhibition Bioassay, For Release And Stability Monitoring Of All New Commercial Product Lots Of Its Mesenchymal Stromal Cell Product Ryoncil

Mesoblast has received FDA approval to implement a new potency assay, the T-Cell Proliferation Inhibition Bioassay (TIBA), for the release and stability monitoring of its mesenchymal stromal cell product, RYONCIL. This assay will enhance the sensitivity to detect potency shifts during manufacturing changes and will be used alongside existing potency assays. RYONCIL is the first FDA-approved allogeneic MSC product for patients with steroid-refractory acute graft versus host disease aged 2 months or older, highlighting its significance in the market.