Ustekinumab (UST) is a monoclonal antibody that belongs to a newly developed class of biological anti-cytokine medications, and is sold under the brand name Stelara. UST can be used to treat psoriasis (including psoriatic arthritis when it affects the skin) and was also approved to treat Crohn's disease in September 2016 by the Food and Drug Administration (FDA). It is directed against interleukin 12 (IL-12) and interleukin 23 (IL-23), naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders.

Figure 1. Structures of IL-12 and IL-23, their receptors and the site of action of UST. (Kotze, P G; 2018)

IL-12 and IL-23 are major players in activating adaptive immunity. Targeting this proinflammatory cytokine pathway has become an area of therapeutic exploration in autoimmune diseases, including psoriasis, psoriatic arthritis, and Crohn's disease. IL-12 is composed of both p40 and p35 subunits, while IL-23 is composed of p40 and p19 subunits. IL-12 receptor is composed of two subunits, such as IL-12Rβ1 and IL-12Rβ2. IL-23 receptor is composed of two subunits, such as IL-12Rβ1 and IL-23R. UST can regulate the immune system and immune-mediated inflammatory disorders, because UST can inhibit IL-12 and IL-23 and prevent the common p40 subunit of IL-12 and IL-23 from interacting with their common receptor IL-12Rβ1, and this can lead to subsequent neutralization of human IL-12- and IL-23-mediated cell signaling, cytokine production and cell activation. UST takes part in the important step of a consequent reduction in the Crohn's disease by regulating the immune system and immune-mediated inflammatory disorders

Ustekinumab Analysis at Creative Proteomics

At Creative Proteomics, we have long-standing experience to support the development of ustekinumab biosimilars. To support the rigorous development of ustekinumab biosimilars, we can provide binding assays, bioassays, as well as physicochemical and structural properties analysis.

Table1. Ustekinumab biosimilars analysis services at Creative Proteomics

Ustekinumab binding assays
  • Ustekinumab IL-12/IL-23 binding assays
  • Ustekinumab C1q assays
Ustekinumab bioassays
  • Ustekinumab IL-12 neutralisation bioassay
Ustekinumab physicochemical analysis          
  • Molecular weight and size
  • Liquid chromatographic patterns
  • Isoform pattern
  • Extinction coefficient, protein concentration analysis
  • Electrophoretic pattern
  • Spectroscopic profiles
Ustekinumab structural analysis
  • Carbohydrate structure
  • Amino acid sequence
  • Amino acid composition
  • Terminal amino acid sequence
  • Peptide mapping
  • Sulfhydryl groups and disulphide bridges

Our Advantages

Our expert scientists have developed a suite of off-the-shelf assay packages to study for a range of biosimilar molecules and an integrated service to support biosimilar development. We also continually develop new methods to support biosimilar characterization and comparability. If you have any questions or specific needs, please do not hesitate to contact us.

1. Kotze, P G; Clinical utility of ustekinumab in Crohn’s disease. Journal of Inflammation Research. 2018, 11: 35–47.

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