Etanercept drug aliquots can be used for in vitro or in vivo experiments. For biosimilar development, different batches of Etanercept drug can be ordered at the same time. Several other reference drugs are also available.
The drug aliquots are generated by aliquoting (dividing and repackaging) the EU-licensed reference drug.
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Up to 10 batches of original drugs for examining batch-to-batch variations
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| Drug name | Enbrel® |
| INN | Etanercept |
| API type | Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system. Etanercept is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand binding domain of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1. This Fc component contains the hinge, CH2and CH3regions, but not the CH1region of IgG1. Etanercept contains 934amino acids and has an apparent molecular weight of approximately 150 kilodaltons. The specific activity of etanercept is 1.7x 106units/mg. |
| Pharmacotherapeutic group | Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors |
| ATC code | L04AB01 |
| Target of antibody | TNF-α; Synonyms: DIF, TNF-alpha, TNFA, TNFSF2, RATTNF, Tnfa, tnf, TNF-a, TNFalpha, Tnfsf1a, TNFa, cTNF, Tnf-alpha, tnfa-like, TNF-ALPHA, dif, tnfa, xtnf, tnfsf2, tnf-alpha, Cachectin |
| General function | |
| Short description | Tumour necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid arthritis. Elevated levels of TNF are also found in the synovium and psoriatic plaques of patients with psoriatic arthritis and in serum and synovial tissue of patients with ankylosing spondylitis. In plaque psoriasis, infiltration by inflammatory cells, including T-cells, leads to increased TNF levels in psoriatic lesions compared with levels in uninvolved skin. Etanercept is a competitive inhibitor of TNF binding to its cell surface receptors, and thereby inhibits the biological activity of TNF. TNF and lymphotoxin are pro-inflammatory cytokines that bind to two distinct cell surface receptors: the 55- kilodalton (p55) and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs). Both TNFRs exist naturally in membrane-bound and soluble forms. Soluble TNFRs are thought to regulate TNF biological activity. TNF and lymphotoxin exist predominantly as homotrimers, with their biological activity dependent on cross-linking of cell surface TNFRs. Dimeric soluble receptors, such as etanercept, possess a higher affinity for TNF than monomeric receptors and are considerably more potent competitive inhibitors of TNF binding to its cellular receptors. In addition, use of an immunoglobulin Fc region as a fusion element in the construction of a dimeric receptor imparts a longer serum half-life. |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Much of the joint pathology in rheumatoid arthritis and ankylosing spondylitis and skin pathology in plaque psoriasis is mediated by pro-inflammatory molecules that are linked in a network controlled by TNF. The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive. Etanercept may also modulate biologic responses controlled by additional downstream molecules (e.g., cytokines, adhesion molecules, or proteinases) that are induced or regulated by TNF. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | |
| Original license holder | |
| Marketing authorisation numbers | EU/1/99/126/001 - 022 |
| Marketing authorisation holder | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom |
| Name of the manufacturer of the biological active substance | Boehringer Ingelheim Pharma KG Birkendorfer Strasse 65 D-88397 Biberach an der Riss Germany Pfizer Ireland Pharmaceuticals Grange Castle Business Park Clondalkin Dublin 22 Ireland |
| Name and address of the manufacturer(s) responsible for batch release | Wyeth Pharmaceuticals New Lane Havant Hampshire, PO9 2NG United Kingdom |
| Max shelf life | 48 months |
| Storage conditions | 2°C – 8°C |
| List of excipients | Powder: Mannitol (E421) Sucrose Trometamol Solvent: Water for injections |
Evidentic offers multiple batches of original drug aliquots in low binding Eppendorf tubes for research use only. We provide licence-free drug aliquots with long, short or even “negative shelf life” by storing the products at recommended temperatures (either 2-8°C or -80°C) and ensuring fully functional molecules for research purposes.
Evidentic GmbH
Martin-Buber-Str. 10
14163 Berlin
