Crizanlizumab is a humanized monoclonal antibody that targets P-selectin, an adhesion molecule involved in interactions between blood cells and the vascular endothelium. It is an immunomodulatory pharmaceutical active ingredient developed for the management of complications associated with sickle cell disease.
Crizanlizumab is a humanized IgG2 kappa monoclonal antibody that selectively binds to P-selectin. By inhibiting P-selectin-mediated interactions, crizanlizumab reduces adhesion between sickled red blood cells, platelets, endothelial cells and leukocytes, helping to reduce vaso-occlusive events.
Crizanlizumab is identified by CAS No. 1636803-09-4 and has a molecular weight of approximately 146 kDa. It is a recombinant biological product manufactured using mammalian cell culture technology.
Crizanlizumab binds to P-selectin and blocks its interaction with P-selectin glycoprotein ligand-1 (PSGL-1). This inhibition reduces cellular adhesion and contributes to decreased vaso-occlusion in patients with sickle cell disease.
Crizanlizumab is used to reduce the frequency of vaso-occlusive crises (VOCs) in patients with sickle cell disease. The approved indication and regulatory status may vary according to jurisdiction.
Crizanlizumab can be supplied for applicable pharmaceutical development, research and manufacturing requirements, subject to biological-product quality standards and regulatory requirements.
As a monoclonal antibody, quality assessment should include identity, purity, biological potency, protein concentration, aggregates, charge variants, glycosylation profile, host-cell proteins, residual host-cell DNA, endotoxin and other applicable critical quality attributes.
Final release criteria should always be based on the approved product specification, validated analytical methods and batch-specific Certificate of Analysis (CoA).
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | Conforms to Crizanlizumab identity by validated immunochemical and/or peptide mapping methods |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 0.5% |
| Melting Point | 150°C – 154°C |