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Therapeutic Avelumab antibody from the original Bavencio® commercial drug.
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ProductBatch | Antigen | Molecular Class | Drug Brand | Product Concentration | CoA | Quantity per vial | Storage Temperature | Expiry Date | Price from | |
|---|---|---|---|---|---|---|---|---|---|---|
PD-L1 |
Monoclonal Antibody |
Bavencio® |
20 mg/mL |
– |
2 mg |
-80°C |
01/2021 |
125,10 € |
| Drug name | Bavencio® |
| INN | Avelumab |
| API type | Avelumab is a human monoclonal IgG1 antibody directed against the immunomodulatory cell surface ligand protein PD-L1 and produced in Chinese hamster ovary cells by recombinant DNA technology. |
| Pharmacotherapeutic group | Antineoplastic agents, monoclonal antibodies |
| ATC code | L01XC31 |
| Target of antibody | PD-L1; Synonyms: CD274, B7-H, B7H1, PD-L1, PDCD1L1, PDCD1LG1, PDL1, A530045L16Rik, B7h1, Pdcd1l1, Pdcd1lg1, Pdl1, RGD1566211 |
| General function | Avelumab is used to treat adults with Merkel cell carcinoma (MCC), a rare type of skin cancer when it is metastatic (has spread to other parts of the body). PD-L1 is found on the surface of MCC cells and helps protect tumour cells from the immune system (the body’s natural defences). Avelumab binds to PD-L1, and blocks this protective effect, allowing the immune system to attack the tumour cells. (Source EMA , package leaflet) |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Avelumab is a human immunoglobulin G1 (IgG1) monoclonal antibody directed against programmed death ligand 1 (PD-L1). Avelumab binds PD-L1 and blocks the interaction between PD-L1 and the programmed death 1 (PD-1) and B7.1 receptors. This removes the suppressive effects of PD-L1 on cytotoxic CD8+ T-cells, resulting in the restoration of anti-tumour T-cell responses. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Avelumab has also shown to induce natural killer (NK) cell-mediated direct tumour cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC). |
| Original license holder | Merck Europe B.V. |
| Marketing authorisation numbers | EU/1/17/1214/001 |
| Marketing authorisation holder | Merck Europe B.V. Gustav Mahlerplein 102 1082 MA Amsterdam The Netherlands |
| Name of the manufacturer of the biological active substance | Merck Serono SA Succursale de Corsier-sur-Vevey Chemin du Fenil - Zone Industrielle B, 1804 Corsier-sur-Vevey Switzerland |
| Name and address of the manufacturer(s) responsible for batch release | Merck Serono S.p.A. Via Delle Magnolie 15 (loc. frazione Zona Industriale) 70026 - Modugno (BA) Italy |
| Max shelf life | 24 months |
| Storage conditions | 2°C – 8°C |
| List of excipients | Mannitol Glacial acetic acid Polysorbate 20 Sodium hydroxide |
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