The company’s failure to show its potency assays measured attributes directly related to the mesenchymal stromal cell product’s therapeutic effect highlights the importance of a robust CMC program for complex cell therapies.
Mesoblast's potency assays drew the FDA's attention. (Nancy Pham)
Key Takeaways
Problems with product characterization and potency assay development led to lengthy delays in the approval of Mesoblast’s mesenchymal stromal cell therapy remestemcel for graft-versus-host disease.
Mesoblast’s graft-versus-host disease treatment Ryoncil (remestemcel-L-rknd) exemplifies how shortfalls in product characterization and potency assay...
