BioPharmaSpec provides a complete solution for Bevacizumab/ Avastin comparability, biosimilarity and characterization studies.

Bevacizumab (trade name Avastin) is a recombinant humanized monoclonal antibody that inhibits vascular endothelial growth factor A (VEGF-A). VEGF-A is a crucial component in the stimulation of angiogenesis (the growth of new blood vessels) in diseases including cancer. Bevacizumab is therefore an anti-cancer drug, acting as an angiogenesis inhibitor to slow the growth of new blood vessels.

Biosimilar Characterization Considerations

The guidelines state that Bevacizumab/ Avastin comparability, biosimilarity and characterization 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

  • Antibody-Dependent Cell Cytotoxicity (ADCC) Reporter Bioassay
  • Complement-Dependent Cytotoxicity (CDC) Assay
  • VEGF Reporter Bioassay
  • Binding Assays – ELISA, MSD, BLI
    • VEGF
    • Fc gamma Receptor Assays
    • FcRn Assays
    • C1q
  • Neutralization Assay
  • Proliferation Assays

Product Specific Technical Considerations

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

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