BioPharmaSpec provides a complete solution for Denosumab/Prolia comparability, biosimilarity and characterization studies.

Denosumab (trade name Prolia) is a human IgG2 monoclonal antibody with the primary function of stopping the development of cells which specifically break-down bone. Due to this function, it is approved for the treatment of osteoporosis, bone loss, bone metastases, and giant cell tumor of bone.

Biosimilar Characterization Considerations

The guidelines state that Denosumab/ Prolia comparability, characterization and biosimilarity studies should include determination of physicochemical and structural properties, purity, impurities and quantity in line with ICH Topic Q6B:

Structural Characterization

Physicochemical Characterization

Functional Testing by Custom Biologics

  • RANK IkB Neutralization Assay
  • RANKL Binding Assay
    • ELISA
  • Receptor Binding Assay

Product Specific Technical Considerations

Particular attention should be paid to the Post Translational Modifications (PTMs) including:

  1. Levels of Pyroglutamination
  2. Disulfide bridges and analysis of the various disulfide bridged isoforms
  3. Heavy chain C-terminal Lysine
  4. Glycosylation (in particular, levels of galactosylation and fucosylation)
  5. Deamidation
  6. Oxidation