相关实验视频
Updated: Jun 8, 2025

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In vitro Monitoring of Extracellular pH in Real-Time
Published on: June 3, 2021
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实时自适应内线酸性增强持续的pH控制病毒失活
Jia Sheng Zach Lee1, Tan Dai Nguyen1, Zi Ying Zheng1
1Bioprocessing Technology Institute (BTI), Agency for Science, Technology and Research (A*STAR), Singapore, Republic of Singapore.
Biotechnology journal
|November 8, 2024
概括
这项研究介绍了一种用于连续生物处理的线内病毒无活化系统 (IVIS). 它使用实时自适应控制来精确操纵pH值,确保持续的病毒失活和产品质量,尽管过程变化.
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
- 工艺工程的过程工程.
背景情况:
- 生物制剂的持续下游加工通常依赖于病毒失活的预测模型.
- 由于动态色谱输出 (例如蛋白质标位变化),当前的方法在工艺开发过程中面临挑战.
- 精确控制pH等关键过程参数 (CPP) 对于产品质量的一致性至关重要.
研究的目的:
- 引入和评估用于连续生物处理的线内病毒失活系统 (IVIS).
- 为了证明精确的,实时的pH控制线内病毒失活.
- 将IVIS与捕获色谱相结合,以实现完全连续的下游工艺.
主要方法:
- 开发和实施具有实时自适应控制的线内病毒失活系统 (IVIS).
- 集成IVIS,包括一个卷轴流逆转反应器 (CFIR),与多列捕获色谱系统.
- 使用直线传感器读数,在连续处理过程中精确调节pH值.
主要成果:
- 在±0.15范围内实现了精确的内线pH操纵.
- 展示了13.5分钟的狭窄居住时间分布,相对宽度为0.7.
- 成功地将IVIS与染色学集成为完全连续的下游工作流.
结论:
- 该IVIS可实现准确的,实时的pH控制,用于持续的病毒失活.
- 这一进步改善了CPP的管理,并确保了生物制药制造业的一致的产品质量.
- 该系统为连续下游生物处理提供了强大的解决方案,可适应生产变化.
相关概念视频
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