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:
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:
- Disulfide bridges
- C-terminal Lysine
- Glycosylation (in particular, levels of galactosylation, fucosylation and sialylation, and glycosylation site profiling and occupancy assessment)