通过过程分析技术,最大限度地降低活病毒疫苗的批量变异性
Katherine Forrester1, Thomas R Blanda1, Marena Trauger1
1Process Research & Development, Merck & Co., Inc., Rahway, New Jersey, USA.
Biotechnology progress
|May 22, 2025
概括
优化病毒生产需要精确的收获时间. 过程分析技术 (PAT) 收获触发器显著提高批量一致性和活病毒生物过程的产量,优于传统的基于时间的收获.
科学领域:
- 生物技术是生物技术.
- 病毒学 病毒学
- 工艺工程的过程工程.
背景情况:
- 活病毒生物过程,如Coxsackievirus A21的生物过程,面临显著的病毒标位衰变.
- 最佳的收获时间对于最大限度地提高病毒产量和确保过程效率至关重要.
研究的目的:
- 开发和评估新的过程分析技术 (PAT) 收获触发器,以优化活病毒生物处理收获.
- 与传统方法相比,改善批量对批量的一致性并最大限度地提高病毒产量.
主要方法:
- 使用可活细胞密度,细胞特异性病毒生产率和衰变率创建了一个连续的病毒产品标位模型.
- 使用溶解氧 (DO) 和电容探针开发了三种PAT收获触发器,计算细胞特异性氧吸收率 (OUR).
- 在实验生物过程中,PAT触发器与基于时间的收获进行了比较.
主要成果:
- 与基于时间的收获相比,PAT收获触发器显著降低了收获产量的标准偏差:41% (DO),56% (OUR) 和71% (容量).
- 即使在过程偏差的情况下,PAT触发器也实现了高达87%的峰值病毒标位,而基于时间的收获仅产生了16%.
结论:
- 基于PAT的收获触发器为活病毒生物处理提供了卓越的控制和一致性.
- 这些先进的触发器减轻与病毒衰变和过程可变性相关的产量损失,提高整体生物过程性能.
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