Guide for the Assessment of Clotting Factor Concentrates
Guide for the Assessment of Clotting Factor Concentrates
Guide for the Assessment of Clotting Factor Concentrates
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TABLE 8. CONCENTRATES OF ANTI-THROMBOTIC FACTORS: (A) Anti-thrombin concentratesBRAND COMPANY SITE OF MANU-FACTUREPLASMA SOURCE EXPORT/DOMESTICFRACTIONATION VIRAL INACTIVATION COMMENTSACLOTINE LFB France Western Europe, unpaid Both affinity chromatography, depth filtration Pasteurization, 60º C, 10 hrs20-15 nm nan<strong>of</strong>iltrationAnbinex Grifols Barcelona, Spain 1.United States paid apheresis2.Spain unpaid recovered andapheresisAnti-thrombin GreenCross Seoul, Korea Korea unpaid and United Statespaid apheresis1.Both2. DomesticDouble heparin ligand chromatography Pasteurization, 60º C, 10 hrs; 15nm nan<strong>of</strong>iltationBoth Ion exchange and heparin affinitychromatographyATIII BPL Elstree, England United States paid apheresis Both Cryosupernatant; heparin absorption,sepharose chromatographyKybernin P CSL Behring Marburg,GermanyUnited States, Austria,Germany; paid and unpaidBoth Precipitations and affinitychromatographySpecific activity7.9 ± 0.4 IU/mgPasteurization, 60º C, 10 hrs Specific activitymore than 8.3 IU/mgPasteurization 60º C,10 hrs and dry heat, 80º C, 72 hrsPasteurization, 60º C, 10 hrs No heparin addedNeuart Benesis Osaka, Japan Japan, unpaid Domestic Ethanol fractionation Pasteurization, 60º C, 10 hrs and20 nm nan<strong>of</strong>iltrationThrombate-III Talecris Clayton, NC,USAThrombotrol-VF CSLBioplasmaMelbourne,AustraliaAustralia, New Zealand, unpaid Both Heparin, sepharose and gel filtrationchromatographyEthanol fractionation Pasteurization, 60º C, 10 hrsPasteurization, 60º C, 10 hrs and15 nm nan<strong>of</strong>iltrationSpecific activity 9-10IU/mg(B) Protein C concentratesAnact C(activated proteinC)Kaketsuken Kumamoto,JapanJapan, unpaid Domestic Affinity and ion exchangechromatographyCeprotin Baxter Vienna, Austria United States & Europe Both Cryosupernatant; ion exchange andimmunoaffinity chromatographyPROTEXEL LFB France Western Europe, unpaid Both Ion exchange chromatography andaffininity chromatographyDry heat 65º C., 10 hrs, and 15nm nan<strong>of</strong>iltrationDetergent; vapor heat, 60° <strong>for</strong> 10ht and80° <strong>for</strong> 1 hrSolvent/Detergent(TNBP/polysorbate 80)Albumin added42 <strong>Guide</strong> <strong>for</strong> <strong>the</strong> <strong>Assessment</strong> <strong>of</strong> <strong>Clotting</strong> <strong>Factor</strong> <strong>Concentrates</strong>
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