Therapeutic IL-12-antibody from the original Stelara® commercial drug targeting the IL-12-antigen, also referred to as Stelara® or ustekinumab antibody. Research-relevant quantities are available as licence-free consumable in aliquoted or diluted variant. Therapeutic monoclonal antibodies can be used from researchers in in vitro and in vivo experiments, biosimilar developers can order different batches at the same time.
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Ustekinumab / Stelara
|API type||Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin(IL)-12/23 produced in a murine myeloma cell line using recombinant DNA technology
|Pharmacotherapeutic group||Immunosuppressants, interleukin inhibitors
|Target of antibody||IL-12; Synonyms: CLMF, CLMF2, IL-12B, NKSF, NKSF2, p40, Il-12b, Il12p40, Il-12p40, Il12, IL-12p40, LOC100217488, IL-12p35, Il-12a, Ll12a, p35, IL12p40, IL12B, IL-12 p35
(Mechanism of action; Source EMA document)
|Ustekinumab is a fully human IgG1κ monoclonal antibody that binds with specificity to the shared p40 protein subunit of human cytokines interleukin (IL)-12 and IL-23. Ustekinumab inhibits the bioactivity of human IL-12 and IL-23 by preventing p40 from binding to the IL-12R1 receptor protein expressed on the surface of immune cells. Ustekinumab cannot bind to IL-12 or IL-23 that is already bound to IL-12R1 cell surface receptors. Thus, ustekinumab is not likely to contribute to complement- or antibody-mediated cytotoxicity of cells with IL-12 and/or IL-23 receptors. IL-12 and IL-23 are heterodimeric cytokines secreted by activated antigen presenting cells, such as macrophages and dendritic cells, and both cytokines participate in immune functions; IL-12 stimulates natural killer (NK) cells and drives the differentiation of CD4+ T cells toward the T helper 1 (Th1) phenotype, IL- 23 induces the T helper 17 (Th17) pathway. However, abnormal regulation of IL 12 and IL 23 has been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis and Crohn’s disease.
By binding the shared p40 subunit of IL-12 and IL-23, ustekinumab may exert its clinical effects in psoriasis, psoriatic arthritis and Crohn’s disease through interruption of the Th1 and Th17 cytokine pathways, which are central to the pathology of these diseases.
In patients with Crohn’s disease, treatment with ustekinumab resulted in a decrease in inflammatory markers including C-Reactive Protein (CRP) and fecal calprotectin during the induction phase, which
were then maintained throughout the maintenance phase.
|Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)|
|Original license holder|
|Marketing authorisation numbers||EU/1/08/494/001 - 005
|Marketing authorisation holder||Janssen Sciences Ireland UC
|Name of the manufacturer of the biological active substance||Patheon Biologics LLC
4766 LaGuardia Drive
St. Louis, MO 63134
Janssen Biologics B.V.
NL-2333 CB Leiden
|Name and address of the manufacturer(s) responsible for batch release||Janssen Biologics B.V.
NL-2333 CB Leiden
|Max shelf life||36 months
|Storage conditions||2°C – 8°C
|List of excipients||EDTA disodium salt dihydrate
L-histidine monohydrochloride monohydrate
Water for injection