连接体结构和基珠孔径大小对宿主细胞蛋白质去除在使用多式色谱树脂的单克隆抗体净化过程中的影响
Chigusa Mori1, Eri Iwamoto1, Kenji Kadoi1
1Yokohama R&D Center, JNC CORPORATION, 5-1, Ookawa, Kanazawa-ku, Yokohama, 236-8605, Japan.
Journal of chromatography. A
|July 30, 2024
概括
一种新型的多式染色体树脂有效地从单克隆抗体 (mAb) 净化中去除宿主细胞蛋白 (HCP). 较大的孔径和特定的连接体结构显著提高HCP清除,改善生物制药生产过程.
科学领域:
- 生物技术是生物技术.
- 化学工程是化学工程的重要组成部分.
- 生物制药制造业 生物制药制造业
背景情况:
- 移除宿主细胞蛋白 (HCP) 对单克隆抗体 (mAb) 纯度至关重要.
- 现有的净化方法在高效的HCP清除方面面临挑战.
研究的目的:
- 开发和评估一种新的多式多态染色学 (MMC) 树脂,以增强HCP去除.
- 研究连接物结构和孔径大小对MMC树脂性能的影响.
主要方法:
- 在流通模式下使用MMC树脂净化后蛋白质A色谱溶液.
- 带结构和基珠孔径大小的优化.
- 用模型HCP (转素,BSA,素) 进行化实验,以预测mAb的净化能力.
主要成果:
- HCP 清除效率取决于MMC 配体的疏水分子结构.
- 长链的树脂 (1,12-多德二胺) 显示出优越的性能.
- 较大的孔径基珠 (超过440nm) 显示出最高的HCP去除能力,减少了HCP的三个数量级.
结论:
- 开发的MMC树脂在mAb抛光过程中显著增强了HCP去除.
- 优化带结构和更大的孔径是高效HCP清除的关键.
- 这一进步改善了mAb生物制药生产的下游加工.
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