在细胞疗法中跨越过程多样性,以实现制造工作流程标准化
Marta H G Costa1, Manuel J T Carrondo1, Paula M Alves1
1iBET, Instituto de Biologia Experimental e Tecnológica, Oeiras, Portugal; Instituto de Tecnologia Química e Biológica António Xavier, Universidade Nova de Lisboa, Oeiras, Portugal.
Cytotherapy
|February 28, 2026
概括
制造细胞疗法是复杂的. 本综述探讨了对仿真抗原受体T细胞,诱导多能干细胞和介质干细胞的要求,以确定可扩展,可复制的细胞疗法生产的标准化机会.
科学领域:
- 生物技术是生物技术.
- 细胞治疗学 细胞治疗学
- 工艺工程是过程工程.
背景情况:
- 细胞疗法对治疗疾病有前途,但由于细胞的变异性和不同的生产需求,它们面临着制造方面的挑战.
- 自主和异种细胞疗法生产需要不同的尺度,工作流程和质量控制措施,由于供体变异性而进一步复杂化.
研究的目的:
- 审查和比较各种细胞治疗模式的制造工艺.
- 确定细胞疗法生产中标准化的机会.
- 探索改善细胞疗法制造的技术解决方案.
主要方法:
- 对细胞隔离,扩张,净化,配方和冷保存的上游和下游加工步骤的分析.
- 检查技术解决方案,包括封闭的,自动化的平台和集成的模块化系统.
- 讨论过程分析技术 (PAT),机器学习 (ML) 和人工智能 (AI) 用于过程控制.
主要成果:
- 制造要求在细胞疗法类型 (如CAR T细胞,iPSC衍生产品和MSCs) 上有很大的差异.
- 封闭,自动化和模块化系统提供灵活性,并使标准化成为可能.
- 实时监控和AI/ML可以增强流程控制并识别关键质量属性.
结论:
- 协调细胞疗法制造工作流可以提高可重复性,可扩展性和成本效益.
- 标准化过程将加速新型细胞疗法的开发和采用.
- 跨多个细胞疗法平台的可适应过程步骤对于未来的进步至关重要.
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