创新的固定床生物反应器平台:实现线性可扩展的附着细胞生物制造,通过营养消耗实时预测生物质
Vasiliy N Goral1, Yulong Hong1, Jeffery J Scibek1
1Corning Life Sciences, Corning Incorporated, Corning, New York, USA.
Biotechnology journal
|August 21, 2024
概括
这项研究介绍了一种新的固定床生物反应器,用于可扩展的附着细胞培养,这对于细胞和基因疗法至关重要. 该平台确保了均的流量,最小的剪切应力和高细胞活力,以实现高效的生物制造.
科学领域:
- 生物技术是生物技术.
- 生物工艺工程 生物工艺工程
- 细胞疗法制造业 细胞疗法制造业
背景情况:
- 可扩展的生物制造平台对于推动细胞和基因疗法的发展至关重要.
- 附着细胞培养对大规模生产提出了独特的挑战.
研究的目的:
- 设计和开发一种新的固定床生物反应器,用于可扩展的附着细胞培养.
- 为了优化生物反应器的设计,以保持均的流量和最小的剪切应力.
- 为了证明平台在细胞培养和病毒载体生产中的性能.
主要方法:
- 利用计算流体动力学 (CFD) 建模用于生物反应器设计优化.
- 员工居住时间分布 (RTD) 测量以评估流动特征.
- 进行定期的媒介采样和离线分析,以监测代谢物梯度.
- 开发了基于氧气吸收率的数学模型,用于实时生物质估计.
主要成果:
- 实现了带有插头流量特征和最小剪切应力的均流动.
- 在细胞生长过程中,在生物反应器中观察到最小的代谢物梯度.
- 在自动化细胞采集中证明了高效率 (≈96%) 和可行性 (≈98%).
- 确认了细胞培养和腺相关病毒载体生产的线性可扩展性.
结论:
- 开发的固定床生物反应器平台可以实现可扩展的粘附性基于细胞的生物制造.
- 该平台提供高生产率,强大的过程控制和高效的细胞采集.
- 这项创新通过提高制造能力,支持细胞和基因疗法的进步.
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