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Immunology

Etanercept

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.

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Product Details

Dosage FormSC Injectable (Prefilled Syringe / Autoinjector / Vial)
Strength25 mg, 50 mg
StorageStore at 2–8°C. Do not freeze.
CategoryImmunology
AvailabilityAvailable for Transfer

Indication

Rheumatoid arthritis; polyarticular juvenile idiopathic arthritis; psoriatic arthritis; ankylosing spondylitis; plaque psoriasis (moderate-to-severe).

Mechanism of Action

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.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Etanercept includes comprehensive documentation and support:

Master Formula

Complete formulation with manufacturing parameters, excipient specifications, and process controls.

Analytical Methods

Validated methods for assay, impurities, dissolution, and stability-indicating analysis.

CTD/eCTD Templates

Market-ready regulatory dossier templates — available through Burrard Intelligence subscription.

Stability Data

ICH-compliant stability studies (accelerated and long-term) with detailed protocols.

Manufacturing Protocols

Scale-up procedures, batch records, equipment specifications, and in-process controls.

Expert Support

Direct advisory access to formulation scientists and regulatory specialists throughout transfer.

Ready for Etanercept Technology Transfer?

Our team can deliver the complete know-how package within 2–21 business days. Book a consultation to discuss your specific requirements.

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