Antihemophilic Factor (Recombinant) Recombinate^TM is a glycoprotein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture the CHO cell line secretes recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix, prepared by immobilization of a monclonal antibody directed to factor VIII, is utilized to selectively isolate the rAHF in the medium. The synthesized rAHF produced by the CHO cells has the same biological effects as Antihemophilic Factor (Human) [AHF (Human)] and structurally has a similar combination of heterogenous heavy and light chains as found in AHF (Human).

Recombinate^TM is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant AHF for intravenous injection and is available in single-dose bottles which contain nominally 250, 500 and 1000 International Units per bottle. When reconstituted with the appropriate volume of diluent, it contains the following stabilizers in maximum amounts: 12.5 mg/mL Albumin (Human), 0.20 mg/mL calcium, 1.5 mg/mL polyethylene glycol (3350), 180 mEq/L sodium, 55 mM histidine, 1.5 µg/AHF International Unit (IU) polysorbate-80. Von Willebrand Factor (vWF) is coexpressed with the Antihemophilic Factor (Recombinant) and helps to stabilize it. The final product contains not more than 2 ng vWF/IU rAHF which will not have any clinically relevant effect in patients with von Willebrand's disease. The product contains no preservative.

Manufacturing of Recombinate^TM is shared by Baxter Healthcare Corporation, Hyland Division and Genetics Institute, Inc. The Antihemophilic Factor Concentrate (Recombinant), is produced by Baxter Healthcare Corporation, Hyland Division and Genetics Institute (For Further Manufacturing Use) and subsequently formulated and packaged at Baxter Healthcare Corporation, Hyland Division.

Each bottle of Recombinate^TM is labeled with the AHF activity expressed in IU per bottle. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.

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