"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(antihemophilic factor [recombinant])
Antihemophilic Factor (Recombinant), Bioclate (antihemophilic factor) TM is a glyco-protein 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 monoclonal antibody directed to factor VIII is utilized to selectively isolate the rAHF in the medium. The rAHF produced has the same biological effects as Antihemophilic Factor (Human) [AHF(Human)] and structurally has a similar combination of heterogeneous heavy and light chains as found in AHF (Human).
Bioclate (antihemophilic factor) 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), 1.5 mg/mL polyethylene glycol (3350),180 mEq/L sodium, 55 mM histidine, 1.5 pg/AHF International Unit (IU) polysorbate-80 and 0.20 mg/mL calcium. 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 Willebrands disease. The product contains no preservative.
Manufacturing of Bioclate (antihemophilic factor) TM is shared by Baxter Healthcare Corporation, Hyland Division and Genetics Institute, Inc. Genetics Institute produces Antihemophilic Factor Concentrate (Recombinant) (For Further Manufacturing Use) which is then formulated and packaged at Baxter Healthcare Corporation, Hyland Division.
Each bottle of Bioclate (antihemophilic factor) 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.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Bioclate Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.