Keytruda®
Pembrolizumab is a humanized anti-PD-1 monoclonal antibody. It blocks the PD-1/PD-L1 pathway, reactivating the immune response against tumor cells.
| Dosage Form | IV Injectable (Solution / Lyophilized Powder) |
| Strength | 25 mg/mL; 100 mg/4mL vial |
| Storage | Store at 2–8°C. Do not freeze. |
| Category | Oncology |
| Availability | Available for Transfer |
Melanoma; NSCLC; HNSCC; classical Hodgkin lymphoma; urothelial carcinoma; MSI-H/dMMR cancers; gastric cancer; cervical cancer; hepatocellular carcinoma.
Binds to PD-1 receptor on T cells, blocking interaction with PD-L1/PD-L2 ligands on tumor cells. This releases PD-1 pathway-mediated inhibition of immune response against tumors.
Each Burrard Pharmaceuticals technology transfer package for Pembrolizumab 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 templates — available through Burrard Intelligence subscription.
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.
Our team can deliver the complete know-how package within 2–21 business days. Book a consultation to discuss your specific requirements.