Opdivo®
Nivolumab is a fully human anti-PD-1 monoclonal antibody used in melanoma, lung, renal, and other cancers. Similar to pembrolizumab, it restores anti-tumor immunity.
| Dosage Form | IV Injectable (Solution) |
| Strength | 10 mg/mL; 40 mg, 100 mg, 240 mg vials |
| Storage | Store at 2–8°C. Do not freeze. |
| Category | Oncology |
| Availability | Available for Transfer |
Melanoma; NSCLC; renal cell carcinoma; Hodgkin lymphoma; HNSCC; urothelial carcinoma; hepatocellular carcinoma; colorectal cancer (MSI-H/dMMR).
Binds to PD-1 receptor, blocking PD-L1 and PD-L2 binding, thereby releasing PD-1 pathway-mediated inhibition of anti-tumor immune response.
Each Burrard Pharmaceuticals technology transfer package for Nivolumab includes comprehensive documentation and support:
Complete formulation with manufacturing parameters, excipient specifications, and process controls.
Validated methods for assay, impurities, dissolution, and stability-indicating analysis.
Market-ready regulatory dossier sections for a named territory, scoped per programme.
ICH-compliant stability studies (accelerated and long-term) with detailed protocols.
Scale-up procedures, batch records, equipment specifications, and in-process controls.
Direct advisory access to formulation scientists and regulatory specialists throughout transfer.
Scope and timing for the complete know-how package are confirmed in writing after a confidentiality agreement. Book a consultation to discuss your specific requirements.