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:
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:
- Levels of Pyroglutamination
- Disulfide bridges
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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.