Repatha®
Evolocumab is a PCSK9 inhibitor monoclonal antibody that dramatically lowers LDL cholesterol. Used in familial hypercholesterolemia and established ASCVD.
| Dosage Form | SC Injectable (Prefilled Syringe / Autoinjector) |
| Strength | 140 mg/mL; 420 mg/3.5mL |
| Storage | Store at 2–8°C. May be stored at room temperature (up to 25°C) for up to 30 days. |
| Category | Cardiovascular |
| Availability | Available for Transfer |
Primary hyperlipidemia; HoFH; established ASCVD to reduce cardiovascular events.
Fully human IgG2 monoclonal antibody that binds to PCSK9, preventing PCSK9-mediated LDL receptor degradation. This increases hepatic LDL receptor availability and clearance of LDL-C.
Each Burrard Pharmaceuticals technology transfer package for Evolocumab 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.