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Oncology

Rituximab

MabThera® / Rituxan®

Rituximab is a chimeric monoclonal antibody targeting CD20 on B cells. Used in non-Hodgkin lymphoma, chronic lymphocytic leukemia, and autoimmune conditions.

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Product Details

Dosage FormIV Injectable (Solution)
Strength10 mg/mL; 100 mg, 500 mg vials
StorageStore at 2–8°C. Protect from direct sunlight.
CategoryOncology
AvailabilityAvailable for Transfer

Indication

Non-Hodgkin lymphoma (follicular, DLBCL); chronic lymphocytic leukemia; rheumatoid arthritis; granulomatosis with polyangiitis.

Mechanism of Action

Binds to CD20 antigen on pre-B and mature B lymphocytes, mediating B-cell lysis through complement-dependent cytotoxicity (CDC) and ADCC.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Rituximab 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 Rituximab 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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