In response to the strong demand of biological protein therapeutics, such as monoclonal antibodies (MAbs), continuous downstream process was developed to deliver these molecules while maintaining desired product consistency and quality attributes, and providing manufacturing efficiency and flexibility. Viral safety is a critical quality attribute for biopharmaceuticals, such as MAbs. Evaluation of the viral clearance by the downstream process is a key component of risk mitigation. Protein A chromatography is typically used as an initial capture step for MAbs and efficient for the removal of process-related impurities like Host Cell Proteins (HCP). This step can also contribute to the clearance of potential viral contaminants. Murine Minute Virus (MMV)-spiking experiments were performed at small scale to investigate the impact on the viral clearance efficiency of the way the Protein A chromatography step is carried out, whether in batch or multicolumn mode. Protein A chromatography step using Novasep Sequential MultiColumn Chromatography (SMCC) technology demonstrated no statistical difference in the viral reduction with reduction factor (RF) of 3.7 log10 (vs. RF of 3.8 log10 for batch). The experiments showed also similar viral distribution over the purification cycles and columns. Data confirmed that the viral clearance capacity by the continuous Protein A chromatography step using SMCC technology is maintained and efficient.

中文翻译：

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通过使用顺序多柱色谱的连续蛋白A层析步骤获得的病毒清除能力。

为了响应诸如单克隆抗体（MAbs）等生物蛋白治疗剂的强烈需求，开发了连续的下游工艺以输送这些分子，同时保持所需的产品一致性和质量属性，并提供制造效率和灵活性。病毒安全性是生物药物（例如单克隆抗体）的关键质量属性。通过下游过程评估病毒清除率是减轻风险的关键组成部分。蛋白质A色谱通常用作单克隆抗体的初始捕获步骤，并且对于去除与过程相关的杂质（例如宿主细胞蛋白质（HCP））有效。此步骤也可以有助于清除潜在的病毒污染物。小规模鼠源细小病毒（MMV）加标实验是为了研究蛋白A色谱分离步骤（分批或多柱模式）对病毒清除效率的影响。使用Novasep顺序多柱色谱（SMCC）技术进行的蛋白A色谱分析步骤表明，病毒的还原率与还原因子（RF）为3.7 log10（批次的RF为3.8 log10）无统计学差异。实验还显示了纯化周期和色谱柱上相似的病毒分布。数据证实通过使用SMCC技术的连续蛋白A层析步骤可保持病毒清除能力，并且效率很高。使用Novasep顺序多柱色谱（SMCC）技术进行的蛋白A色谱分析步骤表明，病毒的还原率与还原因子（RF）为3.7 log10（批次的RF为3.8 log10）无统计学差异。实验还显示了纯化周期和色谱柱上相似的病毒分布。数据证实通过使用SMCC技术的连续蛋白A层析步骤可保持病毒清除能力，并且效率很高。使用Novasep顺序多柱色谱（SMCC）技术进行的蛋白A色谱分析步骤表明，病毒的还原率与还原因子（RF）为3.7 log10（批次的RF为3.8 log10）无统计学差异。实验还显示了纯化周期和色谱柱上相似的病毒分布。数据证实通过使用SMCC技术的连续蛋白A层析步骤可保持病毒清除能力，并且效率很高。