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Porcine Circovirus (PCV) Removal by Q Sepharose Fast Flow Chromatography

机译:Q Sepharose快速流色谱法去除猪圆环病毒(PCV)

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The recently discovered contamination of oral rotavirus vaccines led to exposure of millions of infants to porcine circovirus (PCV). PCV was not detected by conventional virus screening tests. Regulatory agencies expect exclusion of adventitious viruses from biological products. Therefore, methods for inactivationlremoval of viruses have to be implemented as an additional safety barrier whenever feasible. However, inactivation or removal of PCV is difficult. PCV is highly resistant to widely used physicochemical inactivation procedures. Circoviruses such as PCV are the smallest viruses known and are not expected to be effectively removed by currently-used virus filters due to the small size of the circovirus particles. Anion exchange chromatography such as Q Sepharose Fast Flow (QSFF) has been shown to effectively remove a range of viruses including parvoviruses. In this study, we investigated PCV1 removal by virus filtration and by QSFF chromatography. As expected, PCV1 could not be effectively removed by virus filtration. However, PCV1 could be effectively removed by QSFF as used during the purification of monoclonal antibodies (mAbs) and a logjo reduction value (LRV) of 4.12 was obtained.
机译:最近发现的口腔轮状病毒疫苗污染导致数以百万计的婴儿接触猪圆环病毒(PCV)。常规病毒筛选测试未检测到PCV。监管机构希望从生物产品中排除不定型病毒。因此,在可行的情况下,必须实施灭活病毒的方法作为附加的安全屏障。但是,很难灭活或去除PCV。 PCV对广泛使用的物理化学灭活程序具有很高的抵抗力。圆环病毒(例如PCV)是已知的最小病毒,由于圆环病毒颗粒的尺寸很小,因此预计不会被当前使用的病毒过滤器有效去除。阴离子交换色谱(例如Q Sepharose Fast Flow(QSFF))已显示可有效去除多种病毒,包括细小病毒。在这项研究中,我们研究了通过病毒过滤和QSFF色谱法去除PCV1的方法。不出所料,不能通过病毒过滤有效地删除PCV1。但是,可以通过纯化单克隆抗体(mAbs)时使用的QSFF有效去除PCV1,获得的logjo降低值(LRV)为4.12。

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