Emicizumab Drug Aliquot | Anti-Clotting Factor IXa and X | Bispecific Therapeutic Antibody

Aliquoted from the original reference drug | Now available for research use

Aliquots of the reference drug Emicizumab are now available as research consumables.

Emicizumab drug aliquots can be used for in vitro or in vivo experiments. For biosimilar development, different batches of Emicizumab 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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Hemlibra® / Emicizumab Reference Product

Drug nameHemlibra®
INNEmicizumab
API typeEmicizumab is a humanised monoclonal modified immunoglobulin G4 (IgG4) antibody produced using recombinant DNA technology in mammalian Chinese Hamster Ovary (CHO) cells
Pharmacotherapeutic group
Antihemorrhagics, other systemic hemostatics
ATC code
B02BX06
Target of antibody
Coagulation factor IX
Coagulation factor X
General functionHemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors or for severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%) without factor VIII inhibitors
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Emicizumab is a humanized monoclonal modified immunoglobulin G4 (IgG4) antibody with a bispecific antibody structure. Emicizumab bridges activated factor IX and factor X to restore the function of missing activated factor VIII that is needed for effective haemostasis. Emicizumab has no structural relationship or sequence homology to factor VIII and, as such, does not induce or enhance the development of direct inhibitors to factor VIII.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)Prophylactic therapy with Hemlibra shortens the aPTT and increases the reported factor VIII activity (using a chromogenic assay with human coagulation factors). These two pharmacodynamic markers do not reflect the true haemostatic effect of emicizumab in vivo (aPTT is overly shortened and reported factor VIII activity may be overestimated) but provide a relative indication of the procoagulant effect of emicizumab.
Original license holder
Marketing authorisation numbers
EU/1/18/1271/001
Marketing authorisation holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Name of the manufacturer of the biological active substance
Chugai Pharma Manufacturing Co., Ltd.
5-1, Ukima 5-Chome
Kita-Ku, Tokyo
115-8543
Japan
Name and address of the manufacturer(s) responsible for batch releaseRoche Austria GmbH
Engelhorngasse 3
1211 Wien
Austria

Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Max shelf life
30 months
Storage conditions
2°C – 8°C (for the original pharmaceutical presentation for the use in humans)
List of excipients
L-Arginine
L-Histidine
L-Aspartic acid
Poloxamer 188
Water for injections

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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.