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在生物制药制造中的膜过程中蛋白质损失

Jiwon Na¹, Ali Behboudi², Jiwon Mun¹

¹Department of Biological Sciences and Bioengineering, Inha University, Incheon, Republic of Korea.

Biotechnology journal

|May 8, 2024

概括

本研究量化了生物制药膜过过程中的蛋白质损失,确定了影响产品产量和制造成本的蛋白质类型和膜特征等关键因素.

科学领域:

生物制药制造业生物制药制造业
分离科学分离科学
工艺工程是过程工程.

背景情况:

产品产量最大化对于高价值生物制药生产的成本效益至关重要.
在膜过过程中,蛋白质吸附和污染导致了显著的,但未得到量化的产量损失.
下游加工涉及多个膜过步骤,每一步都会导致潜在的蛋白质损失.

研究的目的:

综合分析和量化生物制药下游加工中使用的各种膜过系统中的蛋白质损失.
研究蛋白质类型,度,吞吐量和膜特性对蛋白质损失的影响.
建立一种评估生物工艺中蛋白质产量损失的方法.

主要方法:

使用了三种模型蛋白 (牛血清白蛋白,人血清白蛋白,免疫球蛋白G) 与商用膜.
在澄清,病毒去除,超过/透过和无菌过阶段评估的蛋白质损失.
与蛋白质特性,工艺条件和膜形态等参数相关的蛋白质损失.

主要成果:

在不同的膜过步骤中,可归因于吸附和污染的显著蛋白质损失.
鉴定出不同的蛋白质损失模式,受蛋白质类型 (例如,白蛋白与IgG) 和膜孔尺寸/材料的影响.
建立了蛋白质损失与诸如蛋白质度,跨膜压力和总吞吐量等因素之间的相关性.

结论:

膜过过程中的蛋白质损失是影响生物制药整体产量和制造经济性的关键因素.
通过系统分析了解和量化这些损失对于流程优化至关重要.
开发的方法提供了评估和减轻生物工艺开发中的蛋白质产量损失的框架.

关键词:

生物制药制造业生物制药制造业在下游的下游.膜过程过程中的膜.蛋白质的损失蛋白质的损失

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