Mesoblast receives FDA approval for new Ryoncil potency test
- Mesoblast (NASDAQ:MESO) received FDA approval for a new potency testing method for commercial Ryoncil batches.
- The T-cell Proliferation Inhibition BioAssay (TIBA) will support lot release and stability monitoring alongside existing potency tests.
- Ryoncil is approved for steroid-refractory acute graft-versus-host disease in patients aged two months and older.
Mesoblast (NASDAQ:MESO) announced that the U.S. Food and Drug Administration (FDA) has approved the use of a new potency testing method for commercial batches of Ryoncil.
The newly approved T-cell Proliferation Inhibition BioAssay (TIBA) will be used for quality control of future commercial Ryoncil lots, supporting batch release and ongoing stability monitoring.
The assay will be used alongside Mesoblast’s existing potency assays to evaluate product consistency and biological activity.
Ryoncil is an allogeneic cell therapy approved for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in patients aged two months and older.
The FDA approval of the additional potency test provides Mesoblast with another validated analytical tool for monitoring commercial product quality as it continues manufacturing and distribution activities.
