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首页> 外文期刊>Biotechnology Progress >The Effects of Membrane Filters Used in Biopharmaceutical Processes on the Concentration and Composition of Polysorbate 20
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The Effects of Membrane Filters Used in Biopharmaceutical Processes on the Concentration and Composition of Polysorbate 20

机译：生物制药过程中使用的膜过滤器对聚山梨酯20浓度和组成的影响

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摘要

Polysorbate 20 (PS-20) is often included in the formulation for therapeutic proteins to reduce protein aggregation and surface adsorption. During the production process of therapeutic proteins, various membrane filters are used to filter product pools containing PS-20. The purpose of this study is to quantify the effects of these membrane filtration processes on the concentration and composition of PS-20. A quantitative understanding of this process provides the knowledge base for better controlling the consistency of formulation excipients in drug products. PS-20 solutions (without protein) were filtered through either 0.2 pm sterilizing filters or membrane filters with 30 kDa MWCO. The concentration of PS-20 was measured by a mixed-mode chromatography method and a nuclear magnetic resonance spectroscopy (NMR) assay. The composition of PS-20 was characterized by ~1H-NMR and a reverse-phase chromatography method. Non-specific adsorption of PS-20 on both the sterilizing filter and 30 kDa MWCO membrane filter was quantified. Composition of PS-20 was altered after 30 kDa MWCO membrane filtration, possibly because the different interactions between heterogeneous PS-20 components and the 30 kDa MWCO membrane were not uniform. As a result, the retentate after the 30 kDa MWCO membrane filtration step contains no POE sorbitan and increased amount of POE sorbitan di-esters and tri-esters.
机译：聚山梨酯20（PS-20）通常包含在用于治疗性蛋白质的制剂中，以减少蛋白质聚集和表面吸附。在治疗性蛋白质的生产过程中，各种膜过滤器用于过滤包含PS-20的产物库。这项研究的目的是量化这些膜过滤过程对PS-20浓度和组成的影响。对这一过程的定量理解为更好地控制药品中制剂赋形剂的稠度提供了知识基础。将PS-20溶液（不含蛋白质）通过0.2 pm灭菌过滤器或含30 kDa MWCO的膜过滤器过滤。 PS-20的浓度通过混合模式色谱法和核磁共振波谱法（NMR）测定来测量。 PS-20的组成通过〜1H-NMR和反相色谱法表征。量化了PS-20在灭菌过滤器和30 kDa MWCO膜过滤器上的非特异性吸附。过滤30 kDa MWCO膜后，PS-20的组成发生了变化，这可能是由于异质PS-20组分与30 kDa MWCO膜之间的相互作用不同所致。结果，在30kDa MWCO膜过滤步骤之后的渗余物不包含POE脱水山梨糖醇和增加量的POE脱水山梨糖醇二酯和三酯。

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