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Ophthalmics

Ranibizumab

Lucentis®

Ranibizumab is a humanized monoclonal antibody fragment (Fab) that inhibits VEGF-A. Pioneer in intravitreal anti-VEGF therapy.

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Product Details

Dosage FormIntravitreal Injection (Solution)
Strength0.5 mg/0.05mL; 0.3 mg/0.05mL
StorageStore at 2–8°C. Protect from light. Do not freeze.
CategoryOphthalmics
AvailabilityAvailable for Transfer

Indication

Wet AMD; macular edema following RVO; DME; diabetic retinopathy; myopic choroidal neovascularization.

Mechanism of Action

Fab fragment that binds all active isoforms of VEGF-A, preventing VEGF receptor binding and inhibiting endothelial cell proliferation, vascular leakage, and new blood vessel formation.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Ranibizumab 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 Ranibizumab 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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