Ustekinumab Drug Aliquot | Anti-IL-12 | Therapeutic Antibody

Aliquoted from the original reference drug | Now available for research use

Aliquots of the reference drug Ustekinumab are now available as research consumables.

Ustekinumab drug aliquots can be used for in vitro or in vivo experiments. For biosimilar development, different batches of Ustekinumab drug can be ordered at the same time. Several other reference drugs are also available.

The drug aliquots are generated by aliquoting (dividing and repackaging) the EU-licensed reference drug.

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Up to 10 batches of original drugs for examining batch-to-batch variations

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Stelara® / Ustekinumab Reference Product

Drug nameStelara®
INNUstekinumab
API typeUstekinumab 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
ATC code
L04AC05
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
General function
Short description
Pharmacodynamic properties
(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-12R1 receptor protein expressed on the surface of immune cells. Ustekinumab cannot bind to IL-12 or IL-23 that is already bound to IL-12R1 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
Barnahely
Ringaskiddy
Co. Cork
Ireland
Name of the manufacturer of the biological active substance
Patheon Biologics LLC
4766 LaGuardia Drive
St. Louis, MO 63134
USA

Janssen Biologics B.V.
Einsteinweg 101
NL-2333 CB Leiden
The Netherlands
Name and address of the manufacturer(s) responsible for batch releaseJanssen Biologics B.V.
Einsteinweg 101
NL-2333 CB Leiden
The Netherlands
Max shelf life
36 months
Storage conditions
2°C – 8°C
List of excipients
EDTA disodium salt dihydrate
L-histidine
L-histidine monohydrochloride monohydrate
L-methionine
Polysorbate 80
Sucrose
Water for injection

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Our products are empowering researchers worldwide​

Evidentic offers multiple batches of original drug aliquots in low binding Eppendorf tubes for research use only. We provide licence-free drug aliquots with long, short or even “negative shelf life” by storing the products at recommended temperatures (either 2-8°C or -80°C) and ensuring fully functional molecules for research purposes.