Robust Depth Filter Sizing for Centrate Clarification
Robust Depth Filter Sizing for Centrate Clarification
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DOI：
10.1002/btpr.2188
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发表时间：
2015-11-01
影响因子：
2.9
通讯作者：
Zhao, Xiaoyang
中科院分区：
文献类型：
--
作者：
Lutz, Herb;Chefer, Kate;Zhao, Xiaoyang
植入硅藻土的纤维深度过滤器被广泛用于去除胶体细胞碎片，作为哺乳动物细胞培养液收获过程中的二次澄清步骤。与GMP(良好制造规范)环境中的工艺故障相关的高成本突出了对稳健的工艺规模深度过滤器分级的需求，该分级允许(1)过滤介质、生物反应器进料和操作的随机批次差异，以及(2)过滤器尺寸和格式之间的平均性能的系统性缩放差异。在相同条件下用相同分子的连续批次测试的匹配批次深度过滤介质被用来评估过程变异性的来源和大小。1.2-1.6的深度过滤器分级安全系数允许过滤过程补偿批次间的随机工艺差异。在相同条件下同时测试的四种不同设备中的匹配批次深度过滤介质与普通进料一起使用，以评估结垢效果。所有过滤设备都显示
Cellulosic depth filters embedded with diatomaceous earth are widely used to remove colloidal cell debris from centrate as a secondary clarification step during the harvest of mammalian cell culture fluid. The high cost associated with process failure in a GMP (Good Manufacturing Practice) environment highlights the need for a robust process scale depth filter sizing that allows for (1) stochastic batch-to-batch variations from filter media, bioreactor feed and operation, and (2) systematic scaling differences in average performance between filter sizes and formats. Matched-lot depth filter media tested at the same conditions with consecutive batches of the same molecule were used to assess the sources and magnitudes of process variability. Depth filter sizing safety factors of 1.2-1.6 allow a filtration process to compensate for random batch-to-batch process variations. Matched-lot depth filter media in four different devices tested simultaneously at the same conditions was used with a common feed to assess scaling effects. All filter devices showed