单克隆抗体处理中的宿主细胞蛋白:控制,检测和去除
Takao Ito1, Herb Lutz2, Lihan Tan3
1Life Science, Process Solutions, Merck Ltd. (An Affiliate of Merck KGaA, Darmstadt, Germany), Tokyo, Japan.
Biotechnology progress
|March 13, 2024
概括
宿主细胞蛋白 (HCP) 是生物药物的杂质. 尽管在先进的细胞培养中含量更高,但改进的过程有效地将HCP降低到大约10ppm,确保治疗质量.
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
- 工艺工程是过程工程.
背景情况:
- 宿主细胞蛋白 (HCP) 是通过细胞培养产生的治疗性蛋白质中的关键杂质.
- 单克隆抗体 (mAb) 生产通常涉及高细胞密度培养,增加HCP水平.
- 有效的医疗保健专家许可对于确保生物治疗药物的安全性和质量至关重要.
研究的目的:
- 审查在mAb生物处理过程中医疗保健人员的行业趋势.
- 评估下游单位运营的HCP清关能力.
- 确定生物制造中减少HCP的最佳实践.
主要方法:
- 对已实施和新兴的HCP管理技术进行全面评估.
- 对发布的下游处理数据进行元分析,以确定趋势.
- 对分析方法的审查和对高风险医疗保健工作者的理解.
主要成果:
- 细胞密度较高的培养物增加了mAb表达和HCP水平.
- 改进的下游运营可以显著降低HCP度到10ppm.
- 增强下游处理与传统下游处理之间在HCP清算性能上没有显著差异.
结论:
- 分析方法的进步和HCP的理解提高了流程的稳定性.
- 尽管现代细胞培养技术面临挑战,但有效的HCP减少是可以实现的.
- 流程开发的最佳实践对于最小化生物疗法中医疗保健人员至关重要.
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