Prolia (Denosumab)

Prolia (Denosumab) is a human monoclonal antibody IgG2 with a specific affinity toward the Receptor activator of nuclear factor kappa-B ligand (RANKL, RANK-Ligand) protein. RANKL is a key factor in the activation of osteoclasts, central in the resorption of bone tissue to allow bone remodeling.

Target Antigen: RANKL

RANKL interaction with its receptor protein, RANK, on the surface of osteoclasts and their precursors, stimulates osteoclast formation, function and survival.  The regulation of the balance of bone resorption and ossification (the remodeling of bone), is a key axis controlling calcium demand in the body.  Aberrations in this fine control can lead to a situation where bone resorption occurs more quickly than new bone can be produced to replace it.  As a result, the bone becomes fragile and porous, leading to osteoporosis.

Characterization of Denosumab Innovator and Biosimilar Products

Our robustly designed binding assays and bioassays are available to characterize the key features of anti-RANKL monoclonal antibody therapeutics in clone selection and similarity studies.  The approaches offered include evaluation of specific Fab binding to the RANKL, in addition to potency based bioassays specifically related to the interaction of denosumab with the target molecule.  Assays to measure the binding affinity of denosumab for RANKL by SPR are currently in development, along with cell based assay methodologies central to the mechanisms of action of the Prolia.

BioOutsource provides an integrated package for biosimilar comparability assessments including: off-the-shelf binding assays, bioassays and physicochemical and structural characterization. Our integrated package has been designed to reduce development timelines and improve speed to market for biopharmaceutical manufacturers. In addition to our Prolia-specific methods, we offer a range of generic testing and development services to support the manufacture of monoclonal antibodies:

Our research and development scientists continue to develop new assays for Prolia (denosumab). If you require a method that is not listed then please contact our scientists to discuss your requirements.

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