Stelara (ustekinumab)

Stelara (ustekinumab) is fully human IgG1κ monoclonal antibody targeting IL-12/-23, and is approved for sufferers of inflammatory skin complaints (plaque psoriasis and psoriatic arthritis) who have previously exhibited a lack of response to other immunosuppressive therapies.

Target Antigen: IL-12/-23

The Fab domain of Stelara binds to the p40 subunit of IL-12 and IL-23, thus blocking activation of the IL-12Rβ1 receptor. As a result, the Th1 and Th17 cytokine pathways implicated in the pathology of these diseases are suppressed. Interleukin-12 and Interleukin-23 are heterodimeric pro-inflammatory cytokines, comprising the IL-12p40 (IL12B) subunit dimerised with IL-12p35 (IL12A) or IL-23p19 (IL23A), respectively.  The resulting molecules function as pro-growth factors by binding to the IL-12Rβ1 receptor protein expressed on the surface of immune cells (T-cells and Natural Killer cells) driving the stimulation of Th1 and Th17 cytokine pathways, as part of both the innate and adaptive immune response.  In aberrant signalling however, constitutive upregulation of cytokine signalling has significant implications in the molecular basis of autoimmune diseases such as psoriasis, Crohn’s disease and rheumatoid arthritis.  Biological drugs targeting the suppression of IL-12 and IL-23 have been described as having the potential to become the new clinical gold standard in the treatment of such T-cell mediated disorders.

Characterization of Ustekinumab Innovator and Biosimilar Products

BioOutsource offers a range of services to support the rigorous biological assessment of Stelara (ustekinumab) biosimilar molecules. Our off-the-shelf binding assays and bioassays include binding measurements for IL-12, IL-12p40, IL-12p80 and IL-23 target binding, C1q binding, and in addition to this we are pleased to offer an IL-12 neutralization bioassay to characterize the mechanism of action.

Our assays characterize the key features of anti-IL-12/-23 p40 monoclonal antibody therapeutics using robustly-designed binding assays and bioassays for clone selection, characterization and similarity studies. Our approaches include evaluation of the Fab portion derived binding affinities for the p40 subunit of IL-12 and IL-23, coupled with cell based assay methodologies central to the mechanisms of action of Stelara (ustekinumab) interaction with the target molecule. In addition, we offer a range of platform methods to assess physicochemical and structural properties of Ustekinumab innovator and biosimilar products.

BioOutsource provides a range of generic testing and development services to support the manufacture of monoclonal antibodies:

Contact our experts today to discuss your Stelara biosimilar programme.

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