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在抗体净化过程中,定制抛光步骤以有效地去除降解聚酸盐的宿主细胞蛋白

Melanie Maier^1,2, Stefan Schneider^1,3, Linus Weiss^1,3

¹Bioprocess Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.

Biotechnology and bioengineering

|June 10, 2024

概括

这项研究通过在净化过程中去除有问题的宿主细胞蛋白 (HCPs) 来解决生物制药中的聚酸盐降解问题. 定制色谱有效地将单克隆抗体 (mAbs) 与医疗人员分离,确保产品的质量和安全.

科学领域:

生物制药制造业生物制药制造业
蛋白质化学蛋白质化学
染色学分离科学染色学分离科学

背景情况:

单克隆抗体 (mAb) 产品质量取决于移除宿主细胞蛋白 (HCP).
医疗保健人员对多酸盐 (PS) 的酶性水解是生物制药药品的重大挑战.
对于下游净化抛光步骤中的个体HCP行为存在有限的理解.

研究的目的:

为了研究在mAb净化过程中去除特定的聚酸盐降解HCP.
评估阴离子交换 (CEX) 和混合模式染色学 (MMC) 的有效性,以从聚酸盐降解酸盐中分离mAbs.
为了应对mAbs和HCP之间类似的化配置文件的挑战.

主要方法:

在CEX和MMC树脂上进行重组聚酸盐降解化酶和mAb候选物的高通量结合选.
采用了三步策略,包括表面反应模型和微型列进行选.
在较大的列上使用染色学系统进行缩放,验证了优化的分离条件.

主要成果:

成功地从四个单个聚酸盐降解化酶 (CES1F,CES2C,LPLA2和PAF-AH) 中分离了不同的mAb格式.
在保持高的mAb恢复率 (>96%) 的同时,成功删除了特定的医疗保健人员.
证明了mAb固有的特性对于有效地与HCP分离至关重要.

结论:

定制净化过程以利用mAbs和HCP之间的结合和化行为的微妙差异至关重要.
这种方法为开发改进的策略提供了基础,以减轻酶性聚酸盐降解.
增强的净化策略有助于提高生物制药产品的质量和安全性.

关键词:

下游开发的下游发展.宿主细胞蛋白质是宿主细胞中的一种蛋白质.酶酸盐是什么酸盐是什么这是一种单克隆抗体.聚酸盐是一种聚酸盐.

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