Crovalimab is a recombinant humanized monoclonal antibody designed to selectively bind to complement component 5 (C5). It inhibits the terminal complement pathway and is used as a targeted therapy for complement-mediated hematological disorders.
Crovalimab is a recombinant humanized IgG1 monoclonal antibody that binds specifically to complement protein C5. It is engineered to provide sustained inhibition of C5 activity and is administered by subcutaneous injection.
Crovalimab is identified by CAS No. 1802861-14-0 and has an approximate molecular weight of 143 kDa.
Crovalimab binds to complement component C5, preventing its cleavage into C5a and C5b. This inhibits formation of the terminal complement complex and reduces complement-mediated intravascular hemolysis.
Crovalimab is used for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). It may be used in appropriate patients according to the approved prescribing information and regulatory requirements of the relevant jurisdiction.
Crovalimab can be supplied for applicable pharmaceutical development, research and manufacturing requirements, subject to biological-product quality standards and regulatory requirements.
As a recombinant monoclonal antibody, quality evaluation may include identity, protein concentration, purity, biological potency, aggregates, charge variants, glycosylation profile, host-cell proteins, residual host-cell DNA, endotoxin, bioburden and sterility, as applicable.
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 | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |
| Melting Point | 150°C – 154°C |