Protein C Concentrate
Overview
Protein C Concentrate is a plasma-derived therapeutic protein that plays a critical role in regulating blood coagulation. It is purified from human plasma through advanced fractionation techniques to ensure high potency and safety. Clinically, it is used to replace deficient Protein C in patients with congenital or acquired deficiencies, preventing life-threatening thrombotic events. The concentrate is available in lyophilized or liquid formulations, requiring reconstitution before intravenous administration. Its production adheres to strict regulatory guidelines to minimize viral transmission risks, including pathogen reduction steps such as solvent/detergent treatment or nanofiltration.
Physical and Chemical Properties
Protein C is a vitamin K-dependent glycoprotein with a molecular weight of approximately 62,000 Da. In its activated form (APC), it exhibits serine protease activity. The concentrate typically appears as a white lyophilized powder or clear solution when reconstituted, with stability dependent on proper storage conditions. Key biochemical properties include its ability to bind calcium ions and phospholipid membranes, which are essential for its anticoagulant function. The product’s shelf life ranges from 2-3 years when stored refrigerated in its lyophilized form, but reconstituted solutions must be used promptly to avoid degradation.
Main Applications
The primary use of Protein C Concentrate is the treatment and prophylaxis of thromboembolic events in patients with severe hereditary Protein C deficiency, a condition associated with neonatal purpura fulminans and warfarin-induced skin necrosis. It is administered intravenously under medical supervision, with dosing adjusted based on plasma Protein C activity levels. Off-label applications include adjunctive therapy for disseminated intravascular coagulation (DIC) and sepsis, though clinical evidence for these uses is more limited. Research continues to explore its potential anti-inflammatory and endothelial-protective effects in critical care settings.
Safety and Storage
Protein C Concentrate is generally well-tolerated, but hypersensitivity reactions may occur, particularly in patients with known allergies to human plasma products. Thrombotic events have been rarely reported, necessitating monitoring in high-risk patients. Contraindications include hypersensitivity to heparin (if present as a stabilizer). Lyophilized formulations must be stored at 2-8°C, protected from light. Reconstituted solutions should be used immediately or within 8 hours if refrigerated. Strict aseptic techniques are required during preparation to maintain sterility. Transport requires temperature-controlled logistics to preserve efficacy.
B2B Procurement Guide
When procuring Protein C Concentrate, buyers should prioritize suppliers with plasma product manufacturing expertise and certifications (e.g., FDA, EMA approvals). Key considerations include batch-to-blot consistency, viral safety documentation, and compliance with Good Manufacturing Practices (GMP). Contract manufacturing organizations (CMOs) often provide customized formulations or bulk quantities for clinical trials. Pricing varies significantly based on volume, region, and regulatory status. Long-term supply agreements are advisable to mitigate market shortages, especially given the dependence on human plasma sourcing.
Related Manufacturers
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