SUMMARY  

• STELARA (ustekinumab) is a product of Janssen. Please refer to your local labeling for relevant information describing ustekinumab and for a complete list of ingredients.
• Ustekinumab is a fully human IgG1κ monoclonal antibody and is produced by a recombinant cell line. Ustekinumab binds with specificity to the shared p40 protein subunit of human cytokines interleukin (IL)-12 and IL-23.¹
• Using human Ig (hu-Ig) transgenic mice (GenPharm, subsequently acquired by Medarex; Medarex, subsequently acquired by Bristol Myers Squibb), ustekinumab was originally generated with a human genomic library as part of the technology.²
  • In the transgenic mice, four distinct genetic modifications replaced the mouse Ig loci with human antibody transgenes.
  • Overall, after genetic modifications, immunizing the mice with human interleukin-12 (IL-12), and various other steps in the process, the result was the production of a human monoclonal antibody, ustekinumab.
  • Ustekinumab is produced using perfusion fermentation culture. It is purified from the supernatant generated from the fermentation process.
  • The origin of the human genes used is proprietary to the specific companies mentioned. Janssen does not have any information as to the origin of the human genes.
• The excipients of all STELARA formulations have no ingredients from animal or human origin present.^3,4
• The substances used in the manufacturing process of ustekinumab drug substance are not from animal origin or certification is given from suppliers that substances are in compliance with guidelines established by the Note for Guidance on Minimizing the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products.⁵

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 15 April 2024.