在考虑生物工程方面的诱导多能干细胞的扩展:第二部分
Misha Alexander Teale1, Samuel Lukas Schneider1, Stefan Seidel1
1Centre for Cell Cultivation Techniques, Tissue Engineering, and Medical Biology, Institute of Chemistry and Biotechnology, ZHAW Zurich University of Applied Sciences, Grüentalstrasse 14, 8820, Wädenswil, Switzerland.
Applied microbiology and biotechnology
|February 6, 2025
概括
可扩展的单一用途生物反应器的特征是人类诱导的多能干细胞 (hiPSC) 扩张. 优化的操作范围在5天内产生了近5 × 10^9个单元,而不会影响hiPSC质量.
科学领域:
- 生物技术是生物技术.
- 细胞疗法制造业 细胞疗法制造业
- 干细胞工程 干细胞工程
背景情况:
- 来自人类诱导的多能干细胞 (hiPSCs) 的全源细胞疗法有望提供无障碍的医疗保健.
- 强大的生产需要可扩展的单次使用 (SU) 生物反应器系统,以获得足够的hiPSC产量.
- 对于hiPSC扩张的仪器式SU多板和固定床生物反应器的探索较少.
研究的目的:
- 为了表征仪表式SU多板和固定床生物反应器用于hiPSC扩张.
- 为了确定可扩展的hiPSC生产的最佳操作范围.
- 评估生物反应器条件对hiPSC质量和可行性的影响.
主要方法:
- 计算流体动力学 (CFD) 建模以分析生物反应器水力学.
- 实验生物工程方法用于验证CFD发现.
- 关于Xpansion® 10 (多板) 和AscentTM 1 m2 (固定床) 生物反应器的特性.
主要成果:
- 在无血清条件下确定了令人满意的hiPSC扩张的操作范围.
- 优化的范围限制了墙壁剪切应力,同时确保了足够的氧气传输和混合.
- 在5天内生产了近5×10^9个可行的细胞,扩张因子高达35.
- 没有观察到对细胞活力,身份或分化潜力的明显影响.
结论:
- 生物工程表征成功确定了新型SU生物反应器中hiPSC扩展的操作范围.
- Xpansion® 10 和 AscentTM 1 m2 生物反应器可以支持大规模的 hiPSC 生产.
- hiPSC可以承受适度的墙壁剪切应力 (高达8.2 × 10−5 N cm−2) 而不损害质量.
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