FDA approves Mesoblast's new potency assay for commercial Ryoncil release
核心洞察
Mesoblast has received FDA approval to implement a new potency assay, the T-cell Proliferation Inhibition BioAssay (TIBA), for release and stability monitoring of commercial Ryoncil (搜索) lots.
TIBA will be used alongside existing IL-2Ralpha (搜索) inhibition and CAP assays as part of a matrix to release each commercial batch of the MSC therapy.
Ryoncil (搜索) is the first FDA-approved industrially manufactured allogeneic MSC product and the only MSC therapy cleared for steroid-refractory acute graft versus host disease (搜索) in patients aged 2 months and older.
Mesoblast Limited has received FDA approval to implement a new potency assay, the T-cell Proliferation Inhibition BioAssay (TIBA), for release and stability monitoring of all new commercial lots of its mesenchymal stromal cell (MSC) product Ryoncil (搜索) (remestemcel-L-rknd (搜索)). The company said TIBA provides sufficient sensitivity to detect shifts in product potency that could arise from changes in manufacturing processes or production at new facilities.
TIBA will be used as part of a matrix to release each commercial batch of Ryoncil (搜索), alongside the existing potency assays that measure IL-2Ralpha (搜索) inhibition and CAP (Cell Adhesion and Proliferation), as specified in the product's Biologics License. Mesoblast stated that the combined assays support consistency, potency and clinical effectiveness of the product. The company noted it has worked closely with the FDA since Ryoncil's commercial approval to align on manufacturing process advancements and quality control assays.
Ryoncil (搜索) is the first industrially manufactured allogeneic MSC product approved by the FDA for any indication, and the only MSC product approved for steroid-refractory acute graft versus host disease (搜索) (SR-aGvHD) in patients aged 2 months and older. Mesoblast is also developing remestemcel-L for SR-aGvHD in adults and biologic-resistant inflammatory bowel disease (搜索), and rexlemestrocel-L for heart failure (搜索) and chronic low back pain (搜索).