细胞和基因疗法领域的人工智能,机器学习和数字化系统:ISCT行业委员会的一份指导文件
Vincenzo Di Cerbo1, Hannah W Song2, Laura Herbst3
1Cell and Gene Therapy Catapult, London, UK.
Cytotherapy
|June 17, 2025
概括
人工智能 (AI) 和机器学习 (ML) 可以通过增强制造和市场准入来优化细胞和基因疗法 (CGT). 标准化的语言和监管框架对于在CGT中采用AI至关重要,尽管存在数据挑战.
科学领域:
- 生物技术是生物技术.
- 计算生物学 计算生物学
- 治疗开发的治疗方法
背景情况:
- 人工智能 (AI),机器学习 (ML) 和数字工具的整合正在跨行业迅速扩展.
- 细胞和基因疗法 (CGT) 正在越来越多地探索这些先进技术的应用.
- 最近的讨论,包括在国际细胞和基因疗法协会 (ISCT) 的会议上,强调了对AI/ML对CGT优化日益增长的兴趣.
研究的目的:
- 检查AI,ML和数字工具如何优化CGT制造和市场准入.
- 在CGT中为自动化和数字化提供标准化的定义.
- 确定与在CGT中采用AI相关的挑战和风险,并促进最佳实践.
主要方法:
- 分析CGT内部智能生物处理和先进分析领域的现实实例研究.
- 审查来自ISCT会议的讨论,包括2024年ISCT商业化签名系列 (CSS).
- 纳入来自公众调查的数据,以澄清术语和促进最佳实践.
主要成果:
- 人工智能/ML应用显示出提高CGT制造效率和增加市场准入的潜力.
- 在CGT中需要标准化的术语和定义来实现自动化和数字化.
- 人工智能采用的障碍包括需要人工智能验证工具,标准化方法和监管框架的演变.
结论:
- 人工智能和数字工具为推进细胞和基因疗法提供了巨大的潜力.
- 解决数据质量,数据集大小,统计建模和监管监督方面的挑战对于成功实施人工智能至关重要.
- 促进标准化语言和最佳实践对于实现CGT中自动化和数字化的全部好处至关重要.
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