Isatuximab is a chimeric IgG1 monoclonal antibody that targets CD38, a cell-surface glycoprotein highly expressed on malignant plasma cells. It is an important anti-CD38 monoclonal antibody used in multiple myeloma therapy.
By binding to CD38, isatuximab can directly and indirectly promote the destruction of CD38-expressing malignant cells through multiple immune-mediated mechanisms.
Isatuximab is a specialized recombinant monoclonal antibody pharmaceutical ingredient manufactured using mammalian cell-culture technology.
Its quality evaluation requires extensive characterization of biological and physicochemical attributes, including identity, purity, aggregation, charge variants, glycosylation, molecular weight, CD38-binding activity, biological potency, host-cell proteins, residual DNA, endotoxins and sterility.
CAS Number: 946635-39-4
Molecular Formula: C6426H9924N1708O2012S42
Molecular Weight: Approximately 148 kDa
Molecule Type: Recombinant Chimeric Monoclonal Antibody
Drug Class: Antineoplastic Agent
Pharmacological Class: Anti-CD38 Monoclonal Antibody
Therapeutic Class: Antineoplastic / Immunotherapy
Therapeutic Area: Oncology / Hematology
Isatuximab binds to CD38, a transmembrane glycoprotein expressed at high levels on multiple myeloma cells.
CD38 binding can result in several antitumor mechanisms, including:
Through these mechanisms, isatuximab contributes to the elimination of malignant plasma cells.
Isatuximab is used in combination regimens for the treatment of multiple myeloma in appropriate patients.
It has been used in combination with other antimyeloma agents, including:
The specific indication, treatment line and combination depend on the applicable regulatory approval.
CD38 is expressed on plasma cells and plays roles in NAD metabolism, calcium signaling and immune-cell biology. Its high expression on malignant plasma cells makes it an important therapeutic target in multiple myeloma.
Isatuximab selectively recognizes a specific epitope on CD38 and produces antitumor activity through both immune-mediated and direct mechanisms.
Manufacturing of Isatuximab generally involves:
Isatuximab quality evaluation may include:
Isatuximab drug substance and finished products should be stored according to validated stability data and approved product requirements. Appropriate temperature control is essential to maintain antibody integrity, purity and biological activity.
Isatuximab is relevant to research involving:
Isatuximab is a chimeric IgG1 monoclonal antibody targeting CD38, with CAS Number 946635-39-4 and an approximate molecular weight of 148 kDa. It promotes the elimination of CD38-expressing malignant plasma cells through several immune-mediated and direct mechanisms and is used in combination therapy for multiple myeloma.
| 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 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 4.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |