Ipilimumab is a fully human IgG1 monoclonal antibody that targets cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), an immune checkpoint receptor expressed on activated T cells.
By blocking CTLA-4-mediated inhibitory signaling, ipilimumab enhances T-cell activation and proliferation, thereby strengthening the body's antitumor immune response. It is an important immune checkpoint inhibitor used in oncology.
Ipilimumab is a specialized recombinant monoclonal antibody pharmaceutical ingredient manufactured using mammalian cell-culture technology.
Its quality control requires comprehensive characterization of biological attributes including identity, purity, aggregation, charge variants, glycosylation, molecular weight, potency, CTLA-4 binding activity, host-cell proteins, residual DNA, endotoxins and sterility.
CAS Number: 477202-00-9
Molecular Formula: C6500H10036N1732O2008S48
Molecular Weight: Approximately 148 kDa
Molecule Type: Fully Human Monoclonal Antibody
Drug Class: Immune Checkpoint Inhibitor
Pharmacological Class: Anti-CTLA-4 Monoclonal Antibody
Therapeutic Class: Antineoplastic / Immunotherapy
Therapeutic Area: Oncology
Ipilimumab binds to CTLA-4 and prevents CTLA-4 from interacting with its ligands CD80 and CD86 on antigen-presenting cells.
This removes an inhibitory signal that normally limits T-cell activation. The resulting increase in T-cell activity can enhance recognition and destruction of tumor cells.
Ipilimumab therefore acts by modulating the immune system rather than directly attacking tumor cells.
Ipilimumab is used in approved oncology regimens for selected cancers, including:
Approved indications and combinations depend on the applicable regulatory authorization.
CTLA-4 is an important negative regulator of T-cell responses. By inhibiting CTLA-4, ipilimumab can enhance immune activation against malignant cells.
This mechanism represents a fundamental approach in modern cancer immunotherapy and differs from conventional cytotoxic chemotherapy.
Manufacturing of ipilimumab generally involves:
Ipilimumab quality evaluation may include:
Ipilimumab drug substance and finished pharmaceutical products should be stored according to validated stability data and approved product requirements. Appropriate temperature control is essential to maintain antibody structure, purity and biological activity.
Ipilimumab is relevant to research involving:
Ipilimumab is a fully human IgG1 monoclonal antibody targeting CTLA-4. It has CAS Number 477202-00-9 and an approximate molecular weight of 148 kDa. By blocking CTLA-4-mediated immune inhibition, ipilimumab enhances T-cell activation and is used as an immune checkpoint inhibitor in the treatment of selected cancers.
| 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) | 4.0 – 7.0 |
| Water Content | NMT 0.5% |