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Oncology

Paclitaxel NAB

Abraxane®

Paclitaxel NAB (nanoparticle albumin-bound) is a chemotherapy agent used for the treatment of breast cancer, non-small cell lung cancer (NSCLC), and pancreatic adenocarcinoma. By binding paclitaxel to albumin nanoparticles, it eliminates the need for toxic solvents, improving delivery to tumor tissue and reducing hypersensitivity reactions.

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Product Details

Dosage FormIV Injectable (Lyophilized Powder for Suspension)
Strength100 mg/vial
StorageStore at 20–25°C. Reconstituted suspension stable for 8 hours at 2–8°C.
CategoryOncology
AvailabilityAvailable for Transfer

Indication

Metastatic breast cancer after failure of combination chemotherapy; locally advanced or metastatic NSCLC; metastatic adenocarcinoma of the pancreas.

Mechanism of Action

Paclitaxel promotes microtubule assembly and stabilizes tubulin polymers, preventing depolymerization. This inhibits the normal dynamic reorganization of the microtubule network required for mitosis and cell proliferation.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Paclitaxel NAB 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 Paclitaxel NAB 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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