BioPharmaSpec provides a complete solution for Eculizumab/ Soliris comparability, biosimilarity and characterization studies.
Eculizumab (trade name Soliris) is a human monoclonal antibody that binds to the complement C5 protein, thereby blocking prothrombotic and pro‑inflammatory processes. It is currently used to treat atypical Haemolytic Uraemic Syndrome (aHUS), a rare disease causing inflammation of blood vessels and the formation of blood clots.
Biosimilar Characterization Considerations
The guidelines state that Eculizumab/ Soliris 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
Product Specific Technical Considerations
Particular attention should be paid to the Post Translational Modifications (PTMs) including:
- N-terminal heterogeneity
- Disulfide bridges
- Heavy chain C-terminal Lysine
- Glycosylation (in particular, levels of galactosylation and fucosylation)
- Deamidation
- Oxidation
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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.