Stelara®
Ustekinumab is a fully human anti-IL-12/IL-23 monoclonal antibody. Unique dual-cytokine inhibition provides efficacy across dermatology and gastroenterology.
| Dosage Form | SC Injectable / IV Infusion |
| Strength | 45 mg/0.5mL, 90 mg/mL (SC); 130 mg/26mL (IV) |
| Storage | Store at 2–8°C. Do not freeze or shake. |
| Category | Immunology |
| Availability | Available for Transfer |
Plaque psoriasis (moderate-to-severe); psoriatic arthritis; Crohn's disease (moderate-to-severe); ulcerative colitis (moderate-to-severe).
Binds to the p40 subunit shared by IL-12 and IL-23, preventing their interaction with IL-12Rβ1 on T cells and NK cells. Inhibits Th1 and Th17 inflammatory pathways.
Each Burrard Pharmaceuticals technology transfer package for Ustekinumab includes comprehensive documentation and support:
Complete formulation with manufacturing parameters, excipient specifications, and process controls.
Validated methods for assay, impurities, dissolution, and stability-indicating analysis.
Market-ready regulatory dossier templates — available through Burrard Intelligence subscription.
ICH-compliant stability studies (accelerated and long-term) with detailed protocols.
Scale-up procedures, batch records, equipment specifications, and in-process controls.
Direct advisory access to formulation scientists and regulatory specialists throughout transfer.
Our team can deliver the complete know-how package within 2–21 business days. Book a consultation to discuss your specific requirements.