鼠细小病毒质量对除病毒过滤验证的影响

Effect of murine minute virus quality on virus removal filtration validation

目的探讨鼠细小病毒(murine minute virus,MVM)质量对于除病毒膜过滤验证的影响。方法利用病毒浓缩试剂盒和Sartobind Q离子交换膜在不同条件下对MVM进行两步纯化。采用滤器Virosart HF和Viresolve®Pro Micro Device,使用纯化的MVM进行2种抗体的纳米膜过滤除病毒验证。结果在2种抗体的纳米膜过滤除病毒过程中,加入两步纯化MVM的样品与未加毒的样品相比通量衰减分别仅从9%增至12%和23%,而加入仅经过病毒浓缩试剂盒纯化的MVM分别从9%增至26%和55%。结论MVM纯度的提高可改善除病毒过滤验证中的通量衰减。

Objective To investigate the effect of quality of murine minute virus(MVM)on virus removal filtration validation.Methods MVM was purified under different conditions using virus concentration kit and anion exchange membrane Sartobind Q,and the purified MVM was used for virus removal nanofiltration validation of 2 antibodies by Virosart HF filter and Viresolve®Pro Micro Device filters.Results In nanofiltration of antibodies A and B,compared with samples without MVM,the samples with 2-step purified MVM caused increases of flux decay from 9%to 12%and 23%,respectively,while the increase were from 9%to 26%and 55%for MVM purified only by virus concentration kit.Conclusion Higher purity of virus can improve the flux in virus removal filtration validation.