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提高基于细胞的产品冷保存过程稳定性的策略
Yuki Uno1, Yusuke Hayashi2, Hirokazu Sugiyama2
1Department of Biotechnology, Graduate School of Engineering, The University of Osaka, 2-1 Yamadaoka, Suita-shi, Osaka 565-0871, Japan; Research Base for Cell Manufacturability, Graduate School of Engineering, The University of Osaka, 2-1 Yamadaoka, Suita-shi, Osaka 565-0871, Japan.
Biotechnology advances
|November 20, 2025
概括
可扩展的冷保存对于再生医学中基于细胞的产品至关重要. 本综述详细介绍了在大规模制造过程中保持细胞质量的策略,重点关注分剂,冷,储存和解过程.
科学领域:
- 生物技术是生物技术.
- 再生医学是一种再生医学.
- 细胞疗法制造业 细胞疗法制造业
背景情况:
- 不断扩大的细胞制造市场需要基于细胞的产品 (CBPs) 进行可扩展的冷保存.
- 缩放冷保存过程可能会改变参数,影响CBP的质量稳定性.
- 当前的挑战需要整合工程和生物学方面,以实现强大的CBP冷保存.
研究的目的:
- 审查在冷保存期间提高CBP质量稳定的策略.
- 为了应对细胞治疗制造中的可扩展冷保存的挑战.
- 探索模拟技术在优化冷保存过程中的作用.
主要方法:
- 对冷保存关键阶段的重点审查:发放,冷,储存和解.
- 讨论确保CBP质量稳定的战略.
- 探索用于过程设计和开发的模拟技术.
主要成果:
- 在冷保存扩展期间,确定了影响CBP质量的关键因素.
- 突出了在分发,冷,储存和解过程中保持质量的策略.
- 强调模拟技术对于高效的过程开发的实用性.
结论:
- 设计可扩展的冷保存需要以制造能力为重点的方法,整合工程和生物方面的考虑.
- 模拟技术,包括数字双胞胎,可以显著提高冷保存过程开发的效率和有效性.
- 确保CBP质量稳定对于再生医学和细胞疗法的成功应用至关重要.
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