Lute Scott, Bailey Mark, Combs Jessica, Sukumar Muppalla, Brorson Kurt
Division of Monoclonal Antibodies, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.
Biotechnol Appl Biochem. 2007 Jul;47(Pt 3):141-51. doi: 10.1042/BA20060254.
Retention of a two small phages (PhiX-174 and pp7) by direct-flow small-virus-retentive filters [Viresolve NFP (normal-flow parvovirus), Virosart CPV (canine parvovirus), Ultipor DV20 and Planova 20N] was studied using a commercial-process fluid. Phage passage occurred in each filter type, particularly when overloaded with phage. Clearances of pp7 and PhiX-174 were similar for any given filter brand, arguing that the two phages are equivalent for testing small-virus-retentive filters. The patterns of flux under constant pressure and instantaneous LRV (log reduction value) in relationship to cumulative phage load differed between brands, consistent with the current industry understanding that each brand possesses specific performance attributes. Phages are a powerful and universal tool for evaluating filter performance. Validation of filter performance with phages such as pp7 or PhiX-174 as models for small mammalian viruses represents an attractive alternative to the current practice.
使用一种商业生产过程流体,研究了直流式小病毒截留过滤器[Viresolve NFP(常流细小病毒)、Virosart CPV(犬细小病毒)、Ultipor DV20和Planova 20N]对两种小噬菌体(PhiX - 174和pp7)的截留情况。在每种过滤器类型中都出现了噬菌体透过现象,尤其是当噬菌体过载时。对于任何给定的过滤器品牌,pp7和PhiX - 174的截留率相似,这表明这两种噬菌体在测试小病毒截留过滤器时是等效的。不同品牌在恒压下的通量模式以及瞬时LRV(对数减少值)与累积噬菌体负载的关系有所不同,这与当前行业的认识一致,即每个品牌都具有特定的性能属性。噬菌体是评估过滤器性能的一种强大且通用的工具。用诸如pp7或PhiX - 174等噬菌体作为小型哺乳动物病毒的模型来验证过滤器性能,是当前做法的一个有吸引力的替代方案。