Large‐Scale Production and Properties of a Solvent‐Detergent‐Treated Factor IX Concentrate from Human Plasma

C. Michalski, F. Bal, T. Burnouf, M. Goudemand

研究成果: 雜誌貢獻文章同行評審

37 引文 斯高帕斯(Scopus)


A human solvent-detergent (SD)-treated factor IX concentrate has been produced from cryoprecipitate-poor plasma using DEAE-Sepharose CL-6B and heparin-Sepharose CL-6B chromatography. The DEAE eluate was incubated with an SD mixture [0.3% tri(n-butyl)phosphate-1% Tween 80, 6-h at 24°C] which was found to inactivate, in less than 1 h, more than 3.8 log10 of vesicular stomatitis virus and more than 4.8 log10 of Sindbis virus; the SD was removed by a subsequent heparin adsorption step. The specific activity of the concentrate was 10.9 ± 1.3 IU factor IX:c/mg protein (n=15). The factor IX coagulant to antigen ratio was 0.7 ± 0.1. The concentrate was essentially free of factors II, VII and X, and protein C. The usual major contaminants of prothrombin complex concentrate (PCC) were absent: the concentrate contained about 94% alpha-1 proteins, and only 4 major proteins were resolved by SDS-PAGE (respective apparent molecular weight: 130, 86, 76 and 69 kilodaltons) and by crossed immunoelectrophoresis against an anti-PCC serum. The nonactivated partial thromboplastin time was equivalent to that of PCC; the product was devoid of factor IXa, of other activated procoagulant factors and of coagulant-active phospholipids (removed with SD in the heparin breakthrough fraction). Animal studies using the Wessler test and acute-toxicity test in rabbits revealed no adverse side effects. SD treatment could thus be used to inactivate viruses in factor IX concentrate and improve the safety of replacement therapy in hemophilia B.
頁(從 - 到)202-210
期刊Vox Sanguinis
出版狀態已發佈 - 11月 1988

ASJC Scopus subject areas

  • 血液學


深入研究「Large‐Scale Production and Properties of a Solvent‐Detergent‐Treated Factor IX Concentrate from Human Plasma」主題。共同形成了獨特的指紋。