BioPharmaSpec provides a complete solution for Aflibercept/ Eyelea comparability, biosimilarity and characterization studies.

Aflibercept (trade name Eyelea)  inhibits vascular endothelial growth factor VEGF, due to being a fusion protein of the VEGF binding portions of VEGF receptors 1 and 2 and the Fc portion of IgG1.

Biosimilar Characterization Considerations

The guidelines state that Aflibercept/ Eyelea comparability, biosimilarity and characterization 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

    • Anti-Human Fc
    • FcRn Binding Assay
  • Neutralization Assays
  • Receptor Binding Assays
  • VEGF Binding Assay

Product Specific Technical Considerations

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

  1. Disulfide bridges
  2. C-terminal Lysine
  3. Glycosylation (in particular, levels of galactosylation, fucosylation and sialylation, and glycosylation site profiling and occupancy assessment)
  4. Deamidation
  5. Oxidation