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
- ELISA
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- Anti-Human Fc
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- 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)
- Deamidation
- Oxidation
Need Biosimilar Testing?
BioPharmaSpec scientists have provided data to support many biosimilar development programs for our global client base. Contact our scientists now to understand how we can use our protein characterization methods to accelerate the development of your molecule.