Durvalumab is a recombinant human IgG1κ monoclonal antibody and a programmed death-ligand 1 (PD-L1) blocking agent. It is a biological pharmaceutical product used in oncology. FDA records identify durvalumab under CAS 1428935-60-7 and classify it as an anti-PD-L1 monoclonal antibody.
Durvalumab is a fully human monoclonal antibody that targets PD-L1, a protein involved in regulating immune responses. By binding PD-L1, durvalumab blocks its interaction with PD-1 and CD80 (B7.1), helping release immune inhibition and enhance T-cell-mediated antitumor activity.
Durvalumab is produced through recombinant DNA technology using Chinese hamster ovary (CHO) cell suspension culture. It consists of two identical heavy chains and two identical light chains and contains Fc-region N-linked glycosylation. FDA documentation reports an approximate molecular mass of 149 kDa including oligosaccharides.
Durvalumab binds to PD-L1 and prevents PD-L1 from interacting with PD-1 and CD80. This blockade reduces the immunosuppressive signaling that can limit T-cell activity, thereby supporting an antitumor immune response.
Durvalumab is used in oncology formulations for multiple approved cancer indications, including certain forms of:
The exact indication depends on the approved formulation, treatment combination, patient population and applicable regulatory labeling. FDA's current labeling includes indications for unresectable Stage III NSCLC and other oncology settings.
As a biological monoclonal antibody, Durvalumab quality assessment should focus on critical quality attributes such as identity, purity, potency, aggregation, glycosylation, charge variants, host-cell proteins, residual host-cell DNA, endotoxin and sterility, as applicable to the specific drug substance or drug product specification.
Durvalumab is a specialized oncology biological product requiring controlled recombinant manufacturing and extensive analytical characterization. Pharmaceutical and biotechnology manufacturers can evaluate Durvalumab based on applicable regulatory requirements, quality documentation, validated analytical methods and batch-specific Certificate of Analysis.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | 168°C – 172°C |