Enbrel®
Etanercept is a TNF receptor fusion protein (soluble TNF receptor linked to IgG1 Fc). Unique mechanism as a decoy receptor for both TNF-α and TNF-β.
| Dosage Form | SC Injectable (Prefilled Syringe / Autoinjector / Vial) |
| Strength | 25 mg, 50 mg |
| Storage | Store at 2–8°C. Do not freeze. |
| Category | Immunology |
| Availability | Available for Transfer |
Rheumatoid arthritis; polyarticular juvenile idiopathic arthritis; psoriatic arthritis; ankylosing spondylitis; plaque psoriasis (moderate-to-severe).
Dimeric fusion protein of human TNF receptor 2 (p75) extracellular domain linked to Fc portion of human IgG1. Acts as decoy receptor, binding TNF-α and TNF-β and preventing receptor activation.
Each Burrard Pharmaceuticals technology transfer package for Etanercept 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 sections for a named territory, scoped per programme.
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.
Scope and timing for the complete know-how package are confirmed in writing after a confidentiality agreement. Book a consultation to discuss your specific requirements.