Emicizumab is a recombinant, humanized, bispecific monoclonal antibody designed to bind activated factor IX (FIXa) and factor X (FX). By bringing FIXa and FX together, emicizumab provides a mechanism that restores the function normally provided by activated factor VIII in the coagulation pathway.
Emicizumab is an IgG4-based bispecific antibody produced using genetically engineered Chinese hamster ovary (CHO) cells. It has an approximate molecular weight of 145.6 kDa. The pharmaceutical product is supplied as a sterile, preservative-free, colorless to slightly yellow solution for subcutaneous administration.
Emicizumab is used for routine prophylaxis to prevent or reduce bleeding episodes in people with hemophilia A, including patients with and without factor VIII inhibitors.
| 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% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 5.5 – 6.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |