Efanesoctocog alfa is a recombinant factor VIII-based therapeutic protein designed to provide prolonged factor VIII activity. It is a genetically engineered fusion protein containing recombinant factor VIII linked to the Fc domain of human immunoglobulin G1 and a von Willebrand factor-related polypeptide region. This molecular design extends its circulation time compared with conventional factor VIII products.
Efanesoctocog alfa is used as a replacement therapy for factor VIII deficiency in hemophilia A. It provides factor VIII activity needed for the normal coagulation cascade and helps prevent or control bleeding episodes.
Swapnroop Drugs and Pharmaceuticals provides Efanesoctocog Alfa for pharmaceutical and biopharmaceutical development and manufacturing applications, subject to applicable quality specifications and regulatory requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |