Mesoblast Limited (ASX:MSB) is a global leader in developing allogeneic (off-the-shelf) cellular medicines for severe and life-threatening inflammatory conditions. The company’s therapies modulate multiple effector arms of the immune system to reduce damaging inflammatory processes. Mesoblast announced today that it has received approval from the United States Food and Drug Administration (FDA) to implement a new potency assay for its FDA-approved mesenchymal stromal cell (MSC) product, Ryoncil® (remestemcel-L-rknd). This new T-cell Proliferation Inhibition BioAssay (TIBA) is approved for the release and stability monitoring of all new commercial product lots, a development announced from New York and Melbourne.
The primary objective of the TIBA assay is to provide sufficient sensitivity to detect any shifts in the potency of the commercial product. Such shifts could potentially arise during changes in manufacturing processes or when production occurs in new facilities. The new assay will be integrated into a broader matrix for releasing each commercial batch of Ryoncil®. It will be used in conjunction with existing potency assays, which measure IL-2Ra inhibition and Cell Adhesion and Proliferation (CAP), as specified by the product’s Biologics License. This comprehensive approach aims to ensure that the Ryoncil® product maintains consistency, potency, and clinical effectiveness.
Ryoncil® stands out as the first industrially-manufactured allogeneic MSC product approved by the FDA for any indication. Uniquely, it is the only MSC product cleared for patients aged two months or older with steroid-refractory acute graft versus host disease (SR-aGvHD). Mesoblast and the FDA have maintained close collaboration since Ryoncil®’s initial commercial approval, working together to ensure ongoing alignment on advancements in the product’s manufacturing processes and the implementation of assays crucial for continuous quality control.
