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
- Blinding Assays – IL-12 IL23, C1q
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- ELISA
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- MSD
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- BLI
- IL-12 Neutralization Assay
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)
- 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.