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:

  1. N-terminal heterogeneity
  2. Disulfide bridges
  3. Heavy chain C-terminal Lysine
  4. Glycosylation (in particular, levels of galactosylation and fucosylation)
  5. Deamidation
  6. Oxidation