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Immunology

Dupilumab

Dupixent®

Dupilumab is a fully human anti-IL-4Rα monoclonal antibody that inhibits both IL-4 and IL-13 signaling. Transformative for type 2 inflammatory diseases.

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Product Details

Dosage FormSC Injectable (Prefilled Syringe / Pen)
Strength200 mg, 300 mg
StorageStore at 2–8°C. May store at room temperature (up to 25°C) for up to 14 days.
CategoryImmunology
AvailabilityAvailable for Transfer

Indication

Atopic dermatitis (moderate-to-severe); asthma (eosinophilic/OCS-dependent); chronic rhinosinusitis with nasal polyps; eosinophilic esophagitis; prurigo nodularis; COPD (type 2 inflammation).

Mechanism of Action

Binds to IL-4 receptor alpha subunit, blocking both IL-4 and IL-13 signaling. Inhibits type 2 inflammation by reducing IgE production, eosinophil recruitment, and mucus production.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Dupilumab 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 Dupilumab 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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