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:
Particular attention should be paid to the Post Translational Modifications (PTMs) including:
Levels of Pyroglutamination
Heavy chain C-terminal Lysine
Glycosylation (in particular, levels of galactosylation and fucosylation)
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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.
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