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Immunology

Infliximab

Remicade®

Infliximab is a chimeric anti-TNF-α monoclonal antibody administered by IV infusion. Pioneering biologic for inflammatory conditions with extensive biosimilar market.

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Product Details

Dosage FormIV Injectable (Lyophilized Powder for Reconstitution)
Strength100 mg/vial
StorageStore at 2–8°C. Do not freeze. Reconstituted solution for immediate use.
CategoryImmunology
AvailabilityAvailable for Transfer

Indication

Crohn's disease; ulcerative colitis; rheumatoid arthritis (with methotrexate); ankylosing spondylitis; psoriatic arthritis; plaque psoriasis.

Mechanism of Action

Chimeric IgG1 monoclonal antibody that binds to soluble and transmembrane TNF-α, neutralizing its biological activity and inducing apoptosis of TNF-producing cells.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Infliximab 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 Infliximab 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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