Concizumab is a recombinant humanized IgG4 monoclonal antibody that targets tissue factor pathway inhibitor (TFPI). By binding to TFPI and inhibiting its activity, concizumab allows factor Xa to contribute more effectively to thrombin generation and blood coagulation. It is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.
Concizumab is a biotechnology-derived therapeutic protein used in the development and manufacture of antihemorrhagic treatments for haemophilia. It is marketed as Alhemo and is administered by subcutaneous injection for routine prophylaxis of bleeding in eligible patients with haemophilia A or B.
Concizumab binds to tissue factor pathway inhibitor (TFPI) and prevents TFPI from inhibiting factor Xa. This increases the availability of factor Xa in the coagulation pathway and supports thrombin generation, helping prevent bleeding episodes in haemophilia.
Concizumab is used for routine prophylaxis of bleeding in patients aged 12 years and older with:
The exact approved indication can vary by regulatory jurisdiction. The above indications are listed in the current EMA product information.
Concizumab is formulated as a solution for subcutaneous injection. The EU product is supplied in pre-filled pens at concentrations of 10 mg/mL or 40 mg/mL/100 mg/mL, depending on the presentation.
As a recombinant monoclonal antibody, Concizumab requires biologic-specific characterization rather than the conventional small-molecule API testing approach.
Quality characterization may include:
Exact acceptance criteria should be taken from the approved manufacturer's specification and current CoA.
Concizumab drug product should be stored and handled according to the approved product specification, applicable regulatory labeling and manufacturer instructions. The commercial product is a sterile injectable biologic and requires controlled storage conditions.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Loss on Drying | NMT 1.0% |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.1% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 0.5% |
| Melting Point | 168°C – 172°C |