Hughes B, Bradburne A, Sheppard A, Young D
Glaxo-Wellcome Biotechnology, Beckenham, Kent, UK.
Dev Biol Stand. 1996;88:91-8.
The purification processes used to prepare medicines from human and animal cell lines provide one of the major opportunities for virus risk reduction. The purification process can be validated for its ability to remove a range of viruses and can be shown to provide a significant barrier to the transmission of viruses from cell substrates and raw materials to the patient. Ultrafiltration membranes which are manufactured with extremely tight control on pore size distribution can remove a broad spectrum of viruses with high efficiency. A scheme is described for the evaluation of anti-viral filters and the results from evaluation of two filters are presented. The experiments carried out with ultrafiltration membranes suggest that they can provide significant additional virus risk reduction factors for biopharmaceuticals.
用于从人源和动物细胞系制备药物的纯化工艺为降低病毒风险提供了一个主要机会。纯化工艺可以通过其去除一系列病毒的能力得到验证，并且可以证明它为病毒从细胞基质和原材料向患者的传播提供了一个重要屏障。在孔径分布方面受到极其严格控制而制造的超滤膜能够高效去除广谱病毒。本文描述了一种抗病毒过滤器的评估方案，并给出了两种过滤器的评估结果。使用超滤膜进行的实验表明，它们可为生物制药提供显著的额外病毒风险降低系数。
