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设计考虑影响病毒失活的包装床的流动动力学

Innara Basria¹, Opeyemi Ajayi², Madaisabel FuentesArias¹

¹Division of Pharmaceutical Quality Research VI (DPQR VI), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Pharmaceutical Quality Research (OPQR), Silver Spring, Maryland, USA.

Biotechnology progress

|January 10, 2026

概括

使用包装床反应器 (PBRs) 的持续病毒失活 (CVI) 面临着挑战. 标记物大小会影响预测最低居住时间 (mRT),并且观察到扩大问题,影响病毒失活效率.

科学领域:

生物制药制造业生物制药制造业
化学工程是化学工程的重要组成部分.
过程化学过程化学

背景情况:

单克隆抗体的连续制造正在推进.
持续病毒失活 (CVI) 的实施面临标准化挑战,影响产品质量和安全.
对于CVI,包装床反应堆 (PBR) 的最低停留时间 (mRT) 预测尚未得到充分证实.

研究的目的:

在CVI的PBR中描述居住时间分布 (RTD).
评估痕迹分子特性对mRT预测的影响.
评估CVI的PBR中对mRT的扩大效应.

主要方法:

使用了四个PBR配置.
使用具有不同分子大小的标记物来表征RTD.
在不同的条件和扩展场景下分析了mRT预测.

主要成果:

痕迹分子大小显著影响了mRT预测;较大的分子表现出较短的停留时间.
从16毫米直径的柱子扩大到26毫米直径的柱子没有保持mRT.
传统的染色体扩展原理可能不直接适用于基于PBR的CVI.

结论:

工艺材料的特性,特别是分子大小,影响了CVI的PBR中的mRT预测.
扩展战略需要对CVI PBR进行重新评估.
了解这些因素对于在集成连续制造系统中有效的病毒失活至关重要.

关键词:

生物技术制造业生物技术制造业持续的病毒不活化.流动动力学流动动力学包装床反应堆的反应堆是包装床的反应堆.工艺设计过程设计居住时间的分布.标记器的选择选择的选择.

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