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