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Anaïs Duret¹, Lionel Duarte¹, Laure Cahuzac¹

¹Drug Substance Development, Ichnos Sciences, Switzerland.

Journal of biotechnology

|February 25, 2024

概括

用三丁酸盐 (TnBP) 和聚酸盐80 (PS80) 进行溶剂/洗剂处理,有效地使pH敏感的多特异抗体中的病毒失活. 这种方法可以在净化早期整合,最大限度地减少有毒TnBP暴露,并简化流程.

科学领域:

生物技术是生物技术.
生物制药制造业生物制药制造业
病毒安全病毒安全

背景情况:

多特异性抗体形式提供了新的治疗潜力,但可能对传统的低pH病毒失活方法敏感.
已建立的单克隆抗体 (mAb) 净化平台对于这些新格式是可取的,但pH敏感性是一个挑战.

研究的目的:

评估使用三丁酸盐 (TnBP) 和多酸盐80 (PS80) 的溶剂/洗剂 (S/D) 处理对pH敏感多特异抗体格式的疗效.
评估蛋白A (PA) 捕获期间的替代S/D治疗位置,以增强病毒无活化和过程效率.

主要方法:

用S/D处理 (TnBP/PS80) 应用于含有多特异抗体的澄清细胞培养液 (CCCF).
在净化过程的蛋白A (PA) 捕获步骤中集成S/D处理.
评估病毒失活,病毒减少和S/D组件的去除.

主要成果:

在CCCF中使用S/D治疗成功地使pH敏感的多特异抗体格式的病毒失活.
当在PA捕获阶段应用S/D治疗时,有效的病毒失活和减少,允许累积效应.
从最终产品中证明了完全去除TnBP和PS80.
简化液体处理和尽量减少有毒TnBP的使用.

结论:

用TnBP/PS80进行S/D治疗是一种可行的替代方案,可以对敏感的多特异性抗体格式进行病毒性无活化.
将S/D治疗集成到PA捕获步骤中提供了过程优势,包括增强的病毒安全性和减少TnBP使用.
评估过程确保有效的病毒清除和完全去除S/D试剂.

关键词:

双特异性抗体双特异性抗体蛋白质A亲和力/捕获色谱学净化过程中的净化过程.用溶剂/洗剂进行处理.病毒清除时间病毒的无活化病毒的无活化

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