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Immunology

Adalimumab

Humira®

Adalimumab is a fully human anti-TNF-α monoclonal antibody and the world's first fully human monoclonal antibody. It is one of the best-selling drugs in history.

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Product Details

Dosage FormSC Injectable (Prefilled Syringe / Pen)
Strength10 mg, 20 mg, 40 mg, 80 mg
StorageStore at 2–8°C. Do not freeze. Protect from light.
CategoryImmunology
AvailabilityAvailable for Transfer

Indication

Rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis; Crohn's disease; ulcerative colitis; plaque psoriasis; juvenile idiopathic arthritis; uveitis; hidradenitis suppurativa.

Mechanism of Action

Fully human IgG1 monoclonal antibody that binds specifically to TNF-α, blocking its interaction with p55 and p75 TNF receptors, reducing inflammatory signaling.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Adalimumab 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 Adalimumab 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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