基于模型的生物工艺开发路线图
Khadija Mu'azzam1, Francisco Vitor Santos da Silva2, Jason Murtagh3
1Process & Chemical Engineering, School of Engineering & Architecture, University College Cork, Ireland; DPS Group Cork, Arcadis, Netherlands.
Biotechnology advances
|May 16, 2024
概括
生物制药行业正在转向设计质量 (QbD),以获得更好的产品一致性和效率. 像数字双胞胎这样的工业4.0/5.0技术是实施QbD的关键,尽管面临着整合挑战.
科学领域:
- 生物制药工艺开发 生物制药过程开发
- 生物制品制造业的质量保证
- 工业生物技术 工业生物技术
背景情况:
- 生物制药行业正在从测试质量 (QbT) 过渡到更积极的设计质量 (QbD) 方法.
- QbD将质量纳入流程开发,旨在提高运营效率和缩短上市时间.
- 监管框架通过定义的元素指导QbD实施,例如质量目标产品配置文件 (QTPP) 和关键质量属性 (CQA).
研究的目的:
- 在生物处理中批判性地分析设计质量 (QbD) 实施的关键要素.
- 检查工业4.0和5.0技术在推进QbD方面的变革性作用.
- 审查数字双胞胎 (DTs) 中用于生物处理优化的模型的开发和应用.
主要方法:
- 对QbD原则及其构成要素 (QTPP,CQA,设计空间,控制策略) 的批判性分析.
- 审查工业4.0/5.0技术 (AI,ML,物联网,DTs) 及其对生物加工的影响.
- 探索用于数据技术的建模方法 (机械,实证,混合) 和先进的数据收集技术.
主要成果:
- QbD的实施依赖于定义QTPP,CQA,设计空间和控制策略,以确保产品质量和合规性.
- 工业4.0/5.0技术,特别是数字双胞胎 (DTs),使实时数据分析,预测建模和流程优化成为可能.
- 数据技术在系统集成和数据安全方面面临着挑战,人工智能和先进的通信技术正在解决这些挑战.
结论:
- 像数字双胞胎这样的先进技术的整合对于在生物处理中有效实施QbD至关重要.
- 模型开发和先进的数据收集对于数字双胞胎的准确性和预测能力至关重要.
- 技术和建模方面的持续进步对于优化生物处理和确保产品质量至关重要.
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