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使用阴离子交换混合过器在免疫细胞因子二氧化体融合蛋白净化过程中增强聚合物减少

Jian Ren¹, Alexander Way¹, Chen Wang²

¹Purification Development, Biologics Development & Launch (BDL), Product Development Science & Technology (PDS&T), AbbVie Bioresearch Center, 100 Research Drive, Worcester, MA 01605, USA.

Journal of chromatography. A

|November 25, 2024

概括

制造免疫细胞因子和体融合蛋白面临聚合问题. 恩法兹TM AEX混合净化器有效地去除了聚合物,简化了净化和提高了产品质量.

科学领域:

生物制药制造业生物制药制造业
蛋白质净化蛋白质净化
过技术过技术

背景情况:

免疫细胞因子二体融合蛋白因蛋白质聚合而带来重大制造挑战.
有效的聚合物清除对于实现所需的产品质量和简化下游加工至关重要.

研究的目的:

为了评估深度过器在免疫细胞因子二氧化体融合蛋白制造过程中减轻聚合.
评估EmphazeTM AEX混合净化器在收获澄清和蛋白质A过后的聚合物清除过程中的有效性.

主要方法:

评估各种深度过器,包括EmphazeTM AEX混合净化器,用于收获澄清和中间过.
通过评估操作pH值,料流总量水平和总结结合能力来优化Emphaze过器的性能.
使用静电相互作用原理研究聚合物结合机制.

主要成果:

恩法兹TM AEX混合净化器在收获澄清和蛋白质A过后的过过程中,在清除聚合物方面表现出高效.
提升了预先过器强调过器吞吐量和在收获澄清期间的总量减少.
总量减少了20%以上,大大减少了下游净化工作量.

结论:

恩法兹TM AEX混合净化器是一种有效的解决方案,用于减少免疫细胞因子二氧化体融合蛋白制造中的聚合物.
使用Emphaze过器简化了生物处理,增强了杂质清除,并确保了产品的高质量.
静电相互作用在Emphaze波器的聚合结合机制中起着关键作用.

关键词:

聚合物聚合物聚合物离子汇率离子汇率是什么意思澄清澄清澄清澄清深度过的深度过方法透视身体的身体.聚变蛋白是指聚变蛋白中的一种蛋白.免疫细胞因子是免疫细胞因子.

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