Mesabi Trust, a royalty trust, engages in iron ore mining business in the United States. The company was incorporated in 1961 and is based in New York, New York.
Mesoblast Receives FDA Approval for New Potency Assay to Release Commercial Ryoncil Product
Mesoblast received FDA approval to implement a new potency assay, TIBA, for release and stability monitoring of all new commercial lots of its approved MSC therapy Ryoncil.
The assay adds sensitivity to detect potency shifts during manufacturing changes and will be used alongside existing IL-2Rα inhibition and CAP assays under the product's Biologics License.
The approval supports Mesoblast's ability to scale and modify Ryoncil manufacturing while maintaining quality control on its first and only FDA-approved MSC product.