Inebilizumab is a humanized IgG1 monoclonal antibody that targets CD19, a cell-surface protein expressed on B cells and plasmablasts. It is designed to reduce B-cell populations through antibody-dependent cellular cytotoxicity and other immune-mediated mechanisms.
Inebilizumab is used for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are seropositive for aquaporin-4 (AQP4) antibodies.
Inebilizumab is a specialized biological pharmaceutical ingredient manufactured using recombinant cell-culture technology. Production and purification require stringent control of critical quality attributes associated with monoclonal antibodies.
Quality evaluation may include identity, purity, aggregation, charge variants, glycosylation, potency, host-cell proteins, residual DNA, endotoxins and other process-related impurities.
CAS Number: 1299449-46-3
Molecular Formula: C6472H10020N1724O2028S46
Molecular Weight: Approximately 148 kDa
Molecule Type: Humanized Monoclonal Antibody
Antibody Isotype: IgG1κ
Drug Class: Monoclonal Antibody
Target: CD19
Therapeutic Area: Neurology / Immunology
Inebilizumab binds to CD19, a protein expressed across a broad range of B-cell lineage cells, including plasmablasts.
After binding CD19, the antibody promotes depletion of targeted B cells through immune-mediated mechanisms, including antibody-dependent cellular cytotoxicity (ADCC).
Reduction of B-cell populations decreases the cells involved in the production and maintenance of pathogenic antibodies, which is relevant to the pathophysiology of AQP4-IgG-positive NMOSD.
Inebilizumab is used for:
Its approved therapeutic application is specifically associated with adult AQP4-IgG-positive NMOSD.
NMOSD is an autoimmune inflammatory disorder of the central nervous system that can cause severe attacks affecting the optic nerves and spinal cord.
In patients with AQP4 antibodies, B-cell and antibody-mediated immune mechanisms play an important role. Inebilizumab provides a targeted approach by reducing CD19-positive B-cell populations.
Inebilizumab is produced using recombinant biotechnology in mammalian cell culture. Manufacturing of the antibody drug substance generally involves:
Inebilizumab quality evaluation may include:
Inebilizumab-containing pharmaceutical material should be stored according to validated stability data and approved product requirements. The finished medicinal product requires controlled temperature conditions and protection from unsuitable light and handling conditions.
Inebilizumab is relevant to research involving:
Inebilizumab is a humanized IgG1κ monoclonal antibody targeting CD19. It has CAS Number 1299449-46-3 and an approximate molecular weight of 148 kDa. It is used as a targeted B-cell-depleting therapy for adults with AQP4-IgG-positive neuromyelitis optica spectrum disorder.
| 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 10 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |