Divozilimab is a humanized anti-CD20 monoclonal antibody belonging to the IgG1κ immunoglobulin class. It targets the CD20 antigen expressed on B lymphocytes, resulting in B-cell depletion. Divozilimab is also known by its development code BCD-132.
Divozilimab has CAS Number 2254061-60-2, UNII 13ZEQ1M5ML, and an approximate molecular mass of 145.26 kDa. The FDA substance record identifies it as a humanized IgG1 monoclonal antibody directed against human CD20.
Divozilimab is a recombinant therapeutic monoclonal antibody designed to selectively bind the CD20 antigen on B cells. It belongs to the anti-CD20 monoclonal antibody class and is used as a targeted immunomodulatory therapy.
Divozilimab binds to CD20 (MS4A1) expressed on B lymphocytes. This results in pronounced B-cell depletion and reduces B-cell-mediated immune activity. The mechanism is relevant to diseases in which pathogenic B cells contribute to immune-mediated tissue damage.
Divozilimab has been developed for the treatment of multiple sclerosis, particularly relapsing forms. It has also been investigated for:
IUPHAR reports first approval in Russia in 2023 for relapsing multiple sclerosis, while NMOSD and systemic scleroderma have been investigated in clinical studies.
Divozilimab is a biological pharmaceutical active substance intended for development and manufacture of targeted immunotherapeutic products.
It is supplied as a biologic rather than a conventional small-molecule crystalline API. Pharmaceutical development therefore focuses on parameters such as protein concentration, identity, purity, aggregation, potency, sterility and biological activity.
An Indian CDSCO clinical-trial approval document identifies Divozilimab as a humanized type I anti-CD20 monoclonal antibody and describes a concentrate for solution for infusion at 25 mg/mL.
Important quality attributes for Divozilimab include:
These are biologic-product quality attributes and should be controlled using validated analytical methods.
Divozilimab is a biological protein product and should be handled according to its validated storage conditions and product-specific stability data. Commercial storage conditions should be taken from the applicable approved product documentation and batch-specific CoA.
Divozilimab is relevant to pharmaceutical and biotechnology organizations involved in monoclonal-antibody development, immunology and targeted B-cell therapies.
For commercial procurement, customers should verify the antibody identity, concentration, purity, potency, aggregation profile, sterility, endotoxin level and regulatory documentation.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% by HPLC |
| 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 | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |