Ixekizumab is a humanized IgG4 monoclonal antibody that selectively targets interleukin-17A (IL-17A). It is an immunomodulatory biologic used in the treatment of several chronic inflammatory and immune-mediated diseases, particularly dermatological and rheumatologic conditions.
Ixekizumab binds to IL-17A and inhibits its interaction with the IL-17 receptor, thereby reducing inflammatory signaling involved in disease pathogenesis.
Ixekizumab is a specialized recombinant monoclonal antibody pharmaceutical ingredient produced using mammalian cell-culture technology.
Quality evaluation requires characterization of biological and physicochemical attributes including identity, purity, aggregates, charge variants, glycosylation, molecular integrity, IL-17A binding activity, biological potency, host-cell proteins, residual DNA, endotoxins and sterility.
CAS Number: 1148119-45-0
Molecular Formula: Not applicable as a conventional small molecule
Molecular Weight: Approximately 146 kDa
Drug Class: Immunomodulatory Agent
Pharmacological Class: Anti-IL-17A Monoclonal Antibody
Therapeutic Class: Immunotherapy / Anti-inflammatory Biologic
Therapeutic Area: Dermatology / Rheumatology
Ixekizumab selectively binds to IL-17A, including IL-17A homodimers and IL-17A/F heterodimers.
By neutralizing IL-17A, ixekizumab prevents IL-17A-mediated signaling through its receptor and reduces downstream inflammatory responses.
This can result in:
Ixekizumab is used for selected immune-mediated inflammatory conditions, including:
Specific indications depend on the applicable regulatory approval, patient age and product labeling.
IL-17A is an important inflammatory cytokine involved in host defense and chronic inflammatory disease.
Ixekizumab provides targeted cytokine neutralization, making it relevant to diseases in which excessive IL-17 signaling contributes to inflammation.
Typical manufacturing of ixekizumab may involve:
Ixekizumab quality evaluation may include:
Ixekizumab drug substance and finished products should be stored according to validated stability data and approved product requirements. Appropriate refrigerated storage and protection from freezing, excessive heat and inappropriate light exposure are important for maintaining antibody integrity.
Ixekizumab is relevant to research involving:
Ixekizumab is a humanized IgG4 anti-IL-17A monoclonal antibody with CAS Number 1148119-45-0 and an approximate molecular weight of 146 kDa. It selectively neutralizes IL-17A signaling and is used for selected chronic inflammatory and immune-mediated diseases.
| Parameter | Specification |
|---|---|
| Appearance | 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% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |