"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"...
(Antithrombin III [Human])
Antithrombin III (Human), THROMBATE III® (antithrombin) is a sterile, nonpyrogenic, stable, lyophilized preparation of purified human antithrombin III.
THROMBATE (antithrombin) III is prepared from pooled units of human plasma from normal donors by modifications and refinements of the cold ethanol method of Cohn.1 When reconstituted with Sterile Water for Injection, USP, THROMBATE (antithrombin) III has a pH of 6.0–7.5, a sodium content of 110–210 mEq/L, a chloride content of 110–210 mEq/L, an alanine content of 0.075–0.125 M, and a heparin content of not more than 0.004 unit/IU AT-III. THROMBATE (antithrombin) III contains no preservative and must be administered by the intravenous route. In addition, THROMBATE (antithrombin) III has been heat-treated in solution at 60°C ±0.5°C for not less than 10 hours.
Each vial of THROMBATE III contains the labeled amount of antithrombin III in international units (IU) per vial. The potency assignment has been determined with a standard calibrated against a World Health Organization (WHO) antithrombin III reference preparation.
The manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.24-27
An individual production step in the THROMBATE (antithrombin) III manufacturing process has been shown to decrease TSE infectivity of that experimental model agent. The TSE reduction step is the Effluent I to Effluent II + III fractionation step (6.0 logs). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.
1. Cohn EJ, Strong LE, Hughes WL Jr, et al: Preparation and properties of serum and plasma proteins. IV. A system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids. J Am Chem Soc 68(3):459-75, 1946.
24. Stenland CJ, Lee DC, Brown P, et al. Partitioning of human and sheep forms of the pathogenic prion protein during the purification of therapeutic proteins from human plasma. Transfusion2002. 42(11):1497-500.
25. Lee DC, Stenland CJ, Miller, JL, et al. A direct relationship between the partitioning of the pathogenic prion protein and transmissible spongiform encephalopathy infectivity during the purification of plasma proteins. Transfusion 2001. 41(4):449-55.
26. Lee DC, Stenland CJ, Hartwell, RC, et al. Monitoring plasma processing steps with a sensitive Western blot assay for the detection of the prion protein. J Virol Methods 2000. 84(1):77-89.
27. Cai K, Miller JL, Stenland, CJ, et al. Solvent-dependent precipitation of prion protein. Biochim Biophys Acta 2002. 1597(1):28-35.
Last reviewed on RxList: 10/21/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Thrombate Information
- Thrombate Drug Interactions Center: antithrombin iii (human) iv
- Thrombate Side Effects Center
- Thrombate FDA Approved Prescribing Information including Dosage
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