Hiemstra H, Nieuweboer C E, Idoe M A, Claassen J E, Vos A H, Tersmette M, Strengers P F, Over J, Mauser-Bunschoten E P, Heijboer H
Central Laboratory of The Netherlands Red Cross Blood Transfusion Service, Amsterdam.
Folia Haematol Int Mag Klin Morphol Blutforsch. 1990;117(4):557-63.
In the routine production of a factor VIII concentrate (produced by adsorption of contaminating proteins in cryoprecipitate to controlled-pore silica and concentration of the factor VIII effluent by ultrafiltration) the terminal dry-heat treatment has been replaced by pasteurization in the liquid state. High effectivity of this procedure with respect to virus inactivation was demonstrated using a variety of both lipid- and protein-enveloped model viruses, including HIV. Pair-wise quality control of dry-heated and pasteurized product revealed no significant differences, except in the composition of the formulation buffer. In a clinical study in which 17 patients with haemophilia A participated the pasteurized product was well tolerated and in vivo recovery and half-life of factor VIII were in the same (normal) range as found for the dry-heated counterpart.
在常规生产VIII因子浓缩物时（通过将冷沉淀中的污染蛋白吸附到可控孔径硅胶上，并通过超滤浓缩VIII因子流出液来生产），终端干热处理已被液态巴氏灭菌法所取代。使用包括HIV在内的多种脂质包膜和蛋白包膜模型病毒，证明了该程序在病毒灭活方面的高效性。对干热产品和巴氏灭菌产品进行的成对质量控制显示，除了配方缓冲液的组成外，没有显著差异。在一项有17名甲型血友病患者参与的临床研究中，巴氏灭菌产品耐受性良好，VIII因子的体内回收率和半衰期与干热对照产品处于相同（正常）范围。
