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相关概念视频

Gene Therapy00:59

Gene Therapy

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Gene therapy is a technique where a gene is inserted into a person’s cells to prevent or treat a serious disease. The added gene may be a healthy version of the gene that is mutated in the patient, or it could be a different gene that inactivates or compensates for the patient’s disease-causing gene. For example, in patients with severe combined immunodeficiency (SCID) due to a mutation in the gene for the enzyme adenosine deaminase, a functioning version of the gene can be...
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相关实验视频

Updated: Sep 10, 2025

Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production
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数字模型驱动的细胞和基因治疗过程开发

Evan Claes1,2, Tommy Heck1, Roger Dalmau-Diaz3

  • 1Antleron NV, Leuven, Belgium.

Biotechnology and bioengineering
|August 27, 2025
PubMed
概括
此摘要是机器生成的。

数字模型优化了细胞和基因疗法制造,降低了成本和开发时间. 这种人工智能驱动的方法提高了大规模患者治疗的生产力和可持续性.

关键词:
生物反应器细胞和基因疗法数字模型多个目标过程开发过程优化

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科学领域:

  • 生物技术
  • 工艺工程
  • 复原医学

背景情况:

  • 细胞和基因疗法制造需要工业翻译和成本有效的患者接入.
  • 目前的优化方法耗时且资源密集, 阻碍了可扩展性.
  • 像FDA这样的监管机构鼓励先进的制造方法.

研究的目的:

  • 开发和应用数字模型驱动的框架,以实现细胞和基因治疗制造过程的多目标优化.
  • 在一个固定床生物反应器中优化人类细胞干细胞的扩张.
  • 在过程开发中平衡生产力,成本效益和吞吐量.

主要方法:

  • 整合了混合细胞生长模型与商品成本模型.
  • 进行了2万次体实验以优化培养时间和养策略.
  • 通过实验验证优化过程.

主要成果:

  • 与基准水平相比,成本效益,产量和吞吐量提高了38%.
  • 减少了57%的工艺开发成本和81%的时间.
  • 展示了数字模型的可行性,以实现可持续的多目标流程开发.

结论:

  • 数字模型驱动的优化是细胞和基因治疗过程的重要工具.
  • 这种方法解决了关键的制造需求,并符合有利于人工智能的监管趋势.
  • 该框架使细胞和基因疗法的高效,低成本和可扩展的生产成为可能.