Jorba Nuria, Shitanishi Kenneth T, Winkler Clint J, Herring Steven W
Research and Development Department, Grifols Biologicals Inc., 5555 Valley Boulevard, Los Angeles, CA 90032, USA.
Biologicals. 2014 Sep;42(5):290-3. doi: 10.1016/j.biologicals.2014.06.002. Epub 2014 Jul 4.
Nanofiltration is incorporated into the manufacturing processes of many protein biopharmaceuticals to enhance safety by providing the capacity to retain pathogens while allowing protein drugs to pass through the filter. Retention is mainly a function of size; however, the shape of the pathogen may also influence retention. The ability of the Viresolve(®) Pro nanofilter to remove different sized viruses during the manufacture of a Coagulation Factor IX (Alphanine(®) SD) was studied at varying ionic strength, a process condition with the potential to affect virus shape and, hence, virus retention. Eight viruses were tested in a scale-down of the nanofiltration process. Five of the viruses (EMCV, Reo, BVDV, HIV, PRV) were nanofiltered at normal sodium processing conditions and three (PPV, HAV and WNV) were nanofiltered at higher and lower sodium. Representative Reduction Factors for all viruses were ≥4.50 logs and removal was consistent over a wide range of ionic strength.
纳滤被纳入许多蛋白质生物制药的生产过程中，通过在保留病原体的同时允许蛋白质药物通过过滤器来提高安全性。保留主要取决于大小；然而，病原体的形状也可能影响保留。在不同离子强度下研究了Viresolve(®) Pro纳滤器在凝血因子IX（Alphanine(®) SD）生产过程中去除不同大小病毒的能力，离子强度是一种可能影响病毒形状进而影响病毒保留的工艺条件。在纳滤过程的缩小规模实验中测试了八种病毒。其中五种病毒（脑心肌炎病毒、呼肠孤病毒、牛病毒性腹泻病毒、艾滋病毒、伪狂犬病病毒）在正常钠处理条件下进行纳滤，另外三种病毒（猪细小病毒、甲型肝炎病毒和西尼罗河病毒）在较高和较低钠浓度下进行纳滤。所有病毒的代表性还原因子均≥4.50对数，并且在很宽的离子强度范围内去除效果一致。
