Itolizumab is a humanized IgG1 monoclonal antibody that targets CD6, a cell-surface glycoprotein expressed primarily on T lymphocytes. By binding to CD6, it modulates T-cell activation and signaling and can reduce pro-inflammatory immune responses.
Itolizumab is an immunomodulatory biological therapeutic investigated and used in selected immune-mediated and inflammatory conditions.
Itolizumab is a specialized recombinant monoclonal antibody pharmaceutical ingredient produced using mammalian cell-culture technology.
Quality assessment requires comprehensive characterization of biological and physicochemical attributes, including identity, purity, aggregates, charge variants, glycosylation, molecular weight, CD6-binding activity, biological potency, host-cell proteins, residual DNA, endotoxins and sterility.
CAS Number: 113158-72-4
Molecular Formula: Not applicable as a single defined small-molecule formula
Molecular Weight: Approximately 150 kDa
Molecule Type: Humanized Recombinant Monoclonal Antibody
Drug Class: Immunomodulatory Agent
Pharmacological Class: Anti-CD6 Monoclonal Antibody
Therapeutic Class: Immunotherapy
Therapeutic Area: Immunology / Inflammatory Diseases
Itolizumab binds to CD6, a receptor involved in T-cell activation, differentiation and migration.
CD6 engagement can influence signaling pathways involved in inflammatory immune responses. By targeting CD6, itolizumab can modulate T-cell activity and reduce the production or activity of inflammatory mediators.
Its immunomodulatory effects include:
Itolizumab has been developed for selected immune-mediated and inflammatory diseases, including:
Itolizumab has also been investigated in other inflammatory conditions and disease settings. Specific indications depend on the applicable regulatory approval and product formulation.
CD6 is a co-receptor expressed on T cells and participates in interactions between T cells and antigen-presenting cells.
Targeting CD6 represents an approach to controlling pathological T-cell-mediated inflammation while modulating rather than completely suppressing immune function.
Manufacturing of Itolizumab generally involves:
Itolizumab quality evaluation may include:
Itolizumab drug substance and finished products should be stored according to validated stability data and approved product requirements. Controlled temperature conditions are essential for maintaining antibody integrity, purity and biological activity.
Itolizumab is relevant to research involving:
Itolizumab is a humanized IgG1 anti-CD6 monoclonal antibody with an approximate molecular weight of 150 kDa. It modulates T-cell activation and inflammatory signaling through interaction with CD6 and has been developed for selected immune-mediated and inflammatory diseases.
| 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% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |