BioPharmaSpec provides a complete solution for Ranibizumab/ Lucentis comparability, biosimilarity and characterization studies.

Ranibizumab (trade name Lucentis) is a Fab fragment created from the same mouse monoclonal antibody as Bevacizumab and targets Vascular Endothelial Growth Factor (VEGF-A). VEGF-A has been shown to be involved in vascular diseases of the eye and therefore Ranibizumab is used as an anti-angiogenic treatment for age-related macular degeneration (AMD/ ARMD).

Biosimilar Characterization Considerations

The guidelines state that Ranibizumab/ Lucentis comparability and 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

  • VEGF Neutralization Assay
  • VEGF Reporter Bioassay
  • Binding Assays

Product Specific Technical Considerations

In addition to assessing the consistency of the heavy chain C-terminus, particular attention should be paid to the Post Translational Modifications (PTMs) including:

  1. Levels of Pyroglutamination
  2. Disulfide bridges
  3. Deamidation
  4. Oxidation