Herceptin®
Trastuzumab is a humanized monoclonal antibody targeting the HER2 receptor. Used in HER2-positive breast cancer and gastric cancer.
| Dosage Form | IV Injectable (Lyophilized Powder) |
| Strength | 150 mg, 440 mg vials |
| Storage | Store at 2–8°C. Reconstituted solution stable for 28 days at 2–8°C. |
| Category | Oncology |
| Availability | Available for Transfer |
HER2-overexpressing breast cancer (adjuvant, metastatic); HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Binds to subdomain IV of the extracellular domain of HER2, inhibiting receptor dimerization, signaling, and promoting antibody-dependent cell-mediated cytotoxicity (ADCC).
Each Burrard Pharmaceuticals technology transfer package for Trastuzumab 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.