BioPharmaSpec provides a complete solution for Ustekinumab/ Stelara comparability, biosimilarity and characterization studies.

Ustekinumab (trade name Stelara) is a human monoclonal antibody against interleukin 12 and interleukin 23, which are pro-inflammatory cytokines. Therefore, Ustekinumab is approved to treat inflammatory skin diseases such as psoriasis.

Biosimilar Characterization Considerations

The guidelines state that Ustekinumab/ Stelara comparability 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

Functional Testing by Custom Biologics

  • Binding Assays – IL-12 IL-23, C1q
    • ELISA
    • MSD
    • BLI
  • IL-12 Neutralization Assay

Product Specific Technical Considerations

Particular attention should be paid to the Post Translational Modifications (PTMs) including:

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