Denosumab Bioassay – From Characterization to Release
Denosumab (trade names Prolia and Xgeva) is a human monoclonal antibody for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone. The therapeutic was approved by the FDA in 2010 and the innovator patent ran out at the end of 2017.
Denosumab is a RANKL inhibitor (Receptor Activator of Nuclear Factor Kappa B Ligand), which works by preventing the development of osteoclasts, which are cells that break down bone. With the patent expired, developers are currently working to develop new therapeutics and biosimilars for Denosumab.
Charles River has established a mechanism of action (MoA) reflecting reporter-based bioactivity assay to assess the relative bioactivity of αRANKL test items. The assay is suitable for ICH Q2(R1) compliant method validation, shows stability-indicating properties, and can be used to support the life cycle of a therapeutic from early phase characterization, biocomparability studies, and release of products to the market.