Abatacept drug aliquots can be used for in vitro or in vivo experiments. For biosimilar development, different batches of Abatacept 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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| Drug name | Orencia® |
| INN | Abatacept |
| API type | Abatacept is a fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to a modified Fc portion of human immunoglobulin G1 (IgG1). Abatacept is produced by recombinant DNA technology in Chinese hamster ovary cells. |
| Pharmacotherapeutic group | Immunosuppressants, selective immunosuppressants. |
| ATC code | L04AA24 |
| Target of antibody | TNF alpha |
| General function | Abatacept, in combination with methotrexate, is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor. It is also indicated for the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate. |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Abatacept selectively modulates a key costimulatory signal required for full activation of T lymphocytes expressing CD28. Full activation of T lymphocytes requires two signals provided by antigen presenting cells: recognition of a specific antigen by a T cell receptor (signal 1) and a second, costimulatory signal. A major costimulatory pathway involves the binding of CD80 and CD86 molecules on the surface of antigen presenting cells to the CD28 receptor on T lymphocytes (signal 2). Abatacept selectively inhibits this costimulatory pathway by specifically binding to CD80 and CD86. Studies indicate that naive T lymphocyte responses are more affected by abatacept than memory T lymphocyte responses. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Dose-dependent reductions were observed with abatacept in serum levels of soluble interleukin-2 receptor, a marker of T lymphocyte activation; serum interleukin-6, a product of activated synovial macrophages and fibroblast-like synoviocytes in rheumatoid arthritis; rheumatoid factor, an autoantibody produced by plasma cells; and C-reactive protein, an acute-phase reactant of inflammation. In addition, serum levels of matrix metalloproteinase-3, which produces cartilage destruction and tissue remodelling, were decreased. Reductions in serum TNFα were also observed. |
| Original license holder | Bristol-Myers Squibb Pharma EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland |
| Marketing authorisation numbers | EU/1/07/389/013 |
| Marketing authorisation holder | Bristol-Myers Squibb Pharma EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland |
| Name of the manufacturer of the biological active substance | Bristol-Myers Squibb Co. 38 Jackson Road Devens, MA 01434 USA |
| Name and address of the manufacturer(s) responsible for batch release | CATALENT ANAGNI S.R.L. Loc. Fontana del Ceraso snc Strada Provinciale 12 Casilina, 41 03012 Anagni (FR) Italy Swords Laboratories t/a Bristol-Myers Squibb Cruiserath Biologics Cruiserath Road, Mulhuddart Dublin 15 Ireland |
| Max shelf life | 3 years |
| Storage conditions | 2°C – 8°C |
| List of excipients | Maltose Sodium dihydrogen phosphate monohydrate Sodium chloride |
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
Am Mühlenberg 10
14476 Potsdam | Germany
