Praluent®
Alirocumab is a PCSK9 inhibitor for patients with hypercholesterolemia who cannot achieve adequate LDL-C reduction with statins alone.
| Dosage Form | SC Injectable (Prefilled Pen / Syringe) |
| Strength | 75 mg/mL, 150 mg/mL |
| Storage | Store at 2–8°C. May store at room temperature (up to 25°C) for up to 30 days. |
| Category | Cardiovascular |
| Availability | Available for Transfer |
HeFH; clinical ASCVD requiring additional LDL-C lowering; statin intolerance.
Fully human IgG1 monoclonal antibody that binds to PCSK9, inhibiting PCSK9 binding to LDL receptors and increasing LDL receptor recycling and LDL-C clearance.
Each Burrard Pharmaceuticals technology transfer package for Alirocumab 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.