BioPharmaSpec provides a complete solution for Bevacizumab/ Avastin comparability, biosimilarity and characterization studies.
Bevacizumab (trade name Avastin) is a recombinant humanized monoclonal antibody that inhibits vascular endothelial growth factor A (VEGF-A). VEGF-A is a crucial component in the stimulation of angiogenesis (the growth of new blood vessels) in diseases including cancer. Bevacizumab is therefore an anti-cancer drug, acting as an angiogenesis inhibitor to slow the growth of new blood vessels.
Biosimilar Characterization Considerations
The guidelines state that Bevacizumab/ Avastin comparability, biosimilarity and characterization should include determination of physicochemical and structural properties, purity, impurities and quantity in line with ICH Topic Q6B:
Functional Testing by Custom Biologics
- Antibody-Dependent Cell Cytotoxicity (ADCC) Reporter Bioassay
- Complement-Dependent Cytotoxicity (CDC) Assay
- VEGF Reporter Bioassay
- Binding Assays – ELISA, MSD, BLI
- Fc gamma Receptor Assays
- FcRn Assays
- Neutralization Assay
- Proliferation Assays
Product Specific Technical Considerations
Particular attention should be paid to the Post Translational Modifications (PTMs) including:
- Levels of Pyroglutamination
- Disulfide bridges
- Heavy chain C-terminal Lysine
- Glycosylation (in particular, levels of galactosylation and fucosylation)
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.