Precipitation can be used for the initial purification of monoclonal antibodies (mAbs), with the soluble host cell proteins removed in the permeate by tangential flow microfiltration. The objective of this study was to examine the use of a feed‐and‐bleed configuration to increase the effective conversion (ratio of permeate to feed flow rates) in the hollow fiber module to enable more effective washing of the precipitate. Experiments were performed using human serum Immunoglobulin G (IgG) precipitates formed with 10 mM zinc chloride and 7 wt% polyethylene glycol. The critical flux was evaluated as a function of the shear rate and IgG concentration, with the resulting correlation used to predict conditions that can achieve 90% conversion in a single pass with minimal fouling. Experimental data for both the start‐up and steady‐state performance are in good agreement with model calculations. These results were used to analyze the performance of an enhanced continuous precipitation–microfiltration process using the feed‐and‐bleed configuration for the initial capture / purification of a mAb product.

中文翻译：

---

使用进料和排放配置提高过滤性能以纯化抗体沉淀物

沉淀可用于单克隆抗体 (mAb) 的初步纯化，通过切向流微滤去除渗透物中的可溶性宿主细胞蛋白。本研究的目的是检查进料和排放配置的使用，以提高中空纤维模块中的有效转化率（渗透物与进料流速的比率），从而更有效地洗涤沉淀物。使用由 10 mM 氯化锌和 7 wt% 聚乙二醇形成的人血清免疫球蛋白 G (IgG) 沉淀物进行实验。临界通量被评估为剪切速率和 IgG 浓度的函数，由此产生的相关性用于预测可以在单程中实现 90% 转化率且污染最少的条件。启动和稳态性能的实验数据与模型计算非常吻合。这些结果用于分析增强型连续沉淀-微滤工艺的性能，该工艺使用进料和排放配置进行 mAb 产品的初始捕获/纯化。