Mogamulizumab is a humanized monoclonal antibody that selectively targets CC chemokine receptor 4 (CCR4). It is an anti-CCR4 therapeutic antibody used in oncology, particularly for the treatment of certain T-cell lymphomas.
Mogamulizumab is a complex biological drug substance rather than a conventional small-molecule API. It is an IgG1 kappa monoclonal antibody produced using recombinant DNA technology in mammalian cells.
Mogamulizumab is a specialized biological oncology API used in the development and manufacture of antibody-based pharmaceutical products. Quality control requires characterization of the antibody's identity, purity, potency, glycosylation profile, aggregates, charge variants and other critical quality attributes.
CAS Number: 1262947-49-2
Molecular Formula: Not applicable as a conventional small molecule
Molecular Weight: Approximately 149 kDa
Molecule Type: Recombinant Humanized Monoclonal Antibody
Antibody Class: IgG1 Kappa
Target: CCR4 (CC Chemokine Receptor 4)
Drug Class: Monoclonal Antibody
Therapeutic Class: Antineoplastic / Immunotherapy
Therapeutic Area: Oncology / Hematology
Development Code: KW-0761
Brand Name: POTELIGEO
Because mogamulizumab is a glycoprotein produced biologically, its molecular mass can vary depending on glycosylation and other post-translational characteristics.
Mogamulizumab binds specifically to CCR4, a chemokine receptor expressed on various T-cell populations, including malignant cells in certain T-cell lymphomas.
The antibody is engineered with an enhanced antibody-dependent cellular cytotoxicity (ADCC) profile. Following binding to CCR4-expressing cells, it can promote immune-mediated destruction of targeted cells through Fc-mediated effector mechanisms.
Mogamulizumab API is relevant to:
Mogamulizumab is particularly associated with CCR4-positive T-cell malignancies. Its targeted mechanism provides a research and therapeutic platform for investigating malignant T cells expressing CCR4.
It is used in the development of pharmaceutical products for certain patients with cutaneous T-cell lymphoma (CTCL) and adult T-cell leukemia/lymphoma (ATL), subject to applicable regulatory approvals and labeling.
Mogamulizumab is a humanized IgG1 monoclonal antibody with a molecular mass of approximately 149 kDa. As a recombinant biological molecule, its quality is determined by multiple structural and functional attributes rather than only conventional small-molecule chemical purity.
Important characteristics include:
A controlled mogamulizumab drug-substance manufacturing process may involve:
Typical mogamulizumab quality testing may include:
Mogamulizumab drug substance should be stored under validated temperature-controlled conditions appropriate for the biological material. Protection from excessive temperature variation, light and physical stress is important. Final storage conditions should always follow the approved product specification and validated stability data.
Mogamulizumab is relevant to research involving:
Mogamulizumab is a CCR4-directed humanized IgG1 monoclonal antibody with CAS Number 1262947-49-2 and an approximate molecular weight of 149 kDa. It is a biological oncology drug substance developed for targeted treatment of certain T-cell malignancies and is characterized through extensive structural, biochemical and biological quality testing.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| 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 | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |