Graf E G, Jander E, West A, Pora H, Aranha-Creado H
Pall GmbH Filtrationstechnik, Dreieich, Germany.
Dev Biol Stand. 1999;99:89-94.
Advances in membrane technology have allowed the expansion of the size-exclusion removal principle to viruses of concern in the processing of pharmaceutical drug products derived from biological fluids and cell-culture techniques. Direct flow- and cross-flow filters are complementary techniques for virus removal and may be used either independently or as an adjunct to other virus clearance methods. Representative virus titre reduction data for microfiltration and ultrafiltration membranes are presented along with a validation model using bacteriophages as challenge viruses. Non-destructive filter integrity tests before and after filtration and a stringent process validation regime are applied to enhance product safety.
膜技术的进步使得尺寸排阻去除原理能够扩展到源自生物流体和细胞培养技术的药物产品加工过程中所关注的病毒。直流过滤器和错流过滤器是用于病毒去除的互补技术，可单独使用，也可作为其他病毒清除方法的辅助手段。文中给出了微滤和超滤膜的代表性病毒滴度降低数据，以及使用噬菌体作为挑战病毒的验证模型。在过滤前后进行非破坏性的过滤器完整性测试，并采用严格的工艺验证制度，以提高产品安全性。
