Albutrepenonacog Alfa drug aliquots can be used for in vitro or in vivo experiments. 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 | Idelvion® |
| INN | Albutrepenonacog Alfa |
| API type | Albutrepenonacog Alfa is a purified protein produced by recombinant DNA technology, generated by the genetic fusion of recombinant albumin to recombinant coagulation factor IX. |
| Pharmacotherapeutic group | Antihaemorrhagics, blood coagulation factor IX |
| ATC code | B02BD04 |
| Target of antibody | |
| General function | The genetic fusion of the cDNA of human albumin to the cDNA of human coagulation factor IX enables the protein to be produced as a single recombinant protein and assures product homogeneity by avoiding chemical conjugation. The recombinant factor IX portion is identical to the Thr148 allelic form of plasma-derived factor IX. The cleavable linker between the recombinant factor IX and albumin molecules is derived from the endogenous “activation peptide” in native factor IX. |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton. It is a vitaminK dependent coagulation factor and it is synthesised in the liver. Factor IX is activated by factor XIa in the intrinsic coagulation pathway and by the factor VII/tissue factor complex in the extrinsic pathway. Activated factor IX, in combination with activated factor VIII, activates factor X. Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot is formed. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | The PK parameters following a single injection of 50 IU/kg of Albutrepenonacog Alfa were based on plasma factor IX activity measured by the one-stage clotting assay. The mean factor IX activity at day 7 and day 14 was 13.76% and 6.10%, respectively, after a single dose of 50 IU/kg IDELVION. Repeat PK assessment for up to 30 weeks demonstrated a stable pharmacokinetic profile and incremental recovery was consistent over time. Trough levels of 5-10% have been targeted in clinical studies for achieving bleeding control while on prophylaxis. PK simulations suggest the time to reach 5% plasma FIX activity following a single injection of 50 IU/kg IDELVION to be 12.5 days for adults. |
| Original license holder | |
| Marketing authorisation numbers | EU/1/16/1095/002 |
| Marketing authorisation holder | CSL Behring GmbH Emil-von-Behring-Str. 76 35041 Marburg Germany |
| Name of the manufacturer of the biological active substance | CSL Behring GmbH Emil-von-Behring Strasse 76 35041 Marburg Germany |
| Name and address of the manufacturer(s) responsible for batch release | CSL Behring GmbH Emil-von-Behring Strasse 76 35041 Marburg Germany |
| Max shelf life | 3 years |
| Storage conditions | 2°C – 8°C |
| List of excipients | Powder Sodium citrate Polysorbate 80 Mannitol Sucrose Hydrochloric acid (for pH adjustment) 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
Am Mühlenberg 10
14476 Potsdam | Germany
