Mesoblast (ASX:MSB) secured approval from the US Food and Drug Administration (FDA) to implement a new potency assay, T-cell Proliferation Inhibition BioAssay, for release and monitoring of new commercial product lots of its mesenchymal stromal cell product Ryoncil, according to a Thursday filing with the Australian bourse.
The assay will ensure sensitivity to detect shifts in the potency of the product due to changes in manufacturing processes or production in new facilities and will be used in conjunction with existing potency assays, the filing said.
Shares rose past 2% in morning trade Thursday.