人工智能和机器学习辅助的数字应用程序用于生物制药制造
Shyam Panjwani1, Hao Wei1, John Mason1
1CMC & Technology, Bayer Pharmaceuticals, Berkeley, California, USA.
Biotechnology progress
|November 10, 2025
概括
人工智能 (AI) 和自动化对于复杂的生物制药制造至关重要,提高了生物制药的效率和经济性,例如单克隆抗体,细胞和基因疗法. 这些人工智能应用程序增强了流程理解,监控和监管合规性,最终有利于患者.
科学领域:
- 生物制药制造业 生物制药制造业
- 人工智能在医学中的应用
- 过程自动化 过程自动化
背景情况:
- 生物制造 (单克隆抗体,细胞和基因疗法) 比传统的小分子药物生产更复杂.
- 人工智能 (AI) 和自动化对于解决这些复杂问题越来越重要.
- 现有的AI/ML应用程序显示出增强生物制造业务的潜力.
研究的目的:
- 突出人工智能和自动化在生物制药制造中的重要作用.
- 讨论人工智能应用在生产生物制品方面更有效,更经济的好处.
- 强调人工智能对流程理解,监控和监管合规性的影响.
主要方法:
- 对生物制药行业当前的人工智能和机器学习 (ML) 应用的审查.
- 分析AI/ML研究和云技术方面的进展.
- 检查在单克隆抗体制造中现有的AI/ML使用案例.
- 考虑细胞和基因疗法的未来好处.
主要成果:
- 人工智能应用正在实施,以提高运营效率,流程理解和监控.
- 人工智能采用被监管指导和AI/ML和云技术的进步所加速.
- 在单克隆抗体生产中已经存在成功的AI/ML应用.
- 细胞和基因疗法已经准备好从人工智能集成中显著受益.
结论:
- 人工智能和自动化对于快速,经济高效地制造复杂的生物制品至关重要.
- 人工智能集成改善了生物制造的关键方面,包括监管合规性.
- 人工智能/机器学习和云平台的进步促进了这些变革性技术的开发和部署.
- 人工智能的战略实施最终将通过改进的生物疗法带来更好的患者护理.
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