Chandra Sudhish, Groener A, Feldman F
Aventis Behring, King of Prussia, PA, USA.
Thromb Res. 2002 Mar 1;105(5):391-400. doi: 10.1016/s0049-3848(02)00044-0.
An issue of great importance and continuing concern with regard to all products derived from human plasma is their safety from potential contaminants in the source material from which they are purified. Since viral contaminants are a major safety consideration with these products, a number of different methods, including dry heating, vapor heating, filtration and nanofiltration, ultraviolet and gamma irradiation, pasteurization, solvent/detergent (S/D) treatment, sodium thiocyanate treatment, and chromatography (immunoaffinity, metal chelation, affinity, and ion exchange), have been developed to remove or inactivate potentially contaminating viruses. Pasteurization and S/D treatment have emerged as the dominant viral inactivation methods. Results summarized in this review demonstrate that pasteurization is the broadest and most rigorous currently available method for removal of potential viral contaminants from plasma-derived products. S/D treatment requires control over a large number of manufacturing parameters and has no ability to inactivate nonlipid-enveloped viruses. Pasteurization requires control over only a small number of manufacturing variables, is easily monitored, and remains effective even if deviations are encountered from specified protein and stabilizer concentrations and temperature. In addition, pasteurization is effective against a wide range of lipid- and nonlipid-enveloped viruses.
对于所有源自人血浆的产品而言，一个极为重要且持续受到关注的问题是，这些产品在其纯化所用的原料中潜在污染物方面的安全性。由于病毒污染物是这些产品主要的安全考量因素，已开发出多种不同方法来去除或灭活潜在污染病毒，这些方法包括干热、蒸汽加热、过滤和纳滤、紫外线和伽马射线辐照、巴氏消毒、溶剂/去污剂（S/D）处理、硫氰酸钠处理以及色谱法（免疫亲和、金属螯合、亲和及离子交换）。巴氏消毒和S/D处理已成为主要的病毒灭活方法。本综述中总结的结果表明，巴氏消毒是目前从血浆衍生产品中去除潜在病毒污染物最广泛且最严格的方法。S/D处理需要控制大量生产参数，且无法灭活非脂质包膜病毒。巴氏消毒仅需控制少量生产变量，易于监测，即使在蛋白质和稳定剂浓度及温度偏离规定值时仍保持有效。此外，巴氏消毒对多种脂质包膜和非脂质包膜病毒均有效。
