BioPharmaSpec provides a complete solution for Cetuximab/ Erbitux comparability, biosimilarity and characterization studies.
Cetuximab (trade name Erbitux) is a chimeric monoclonal antibody that inhibits epidermal growth factor receptor (EGFR) and is administered for the treatment of various cancers including colorectal, non-small cell lung and head and neck.
Biosimilar Characterization Considerations
The guidelines state that Cetuximab/ Erbitux comparability and characterization should include determination of physicochemical and structural properties, purity, impurities and quantity in line with ICH Topic Q6B:
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)
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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.