在非生物复杂药物制造中利用Pharma 4.0技术:创新和影响
Vera Malheiro1, Joana Duarte1, Francisco Veiga1,2
1Drug Development and Technology Laboratory, Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal.
Pharmaceutics
|November 25, 2023
概括
像机器学习,in silico建模和3D打印这样的Pharma 4.0技术正在改变非生物复杂药物 (NBCD) 制造. 这些创新提高了效率,安全和质量,数字双胞胎为未来的优化提供了潜力.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 工业技术 工业技术 工业技术 工业技术
- 药物开发 药物开发
背景情况:
- 制药行业正在经历着 Pharma 4.0. 推动的重大转型.
- 非生物复杂药物 (NBCDs) 由于其复杂性而存在独特的制造挑战.
- 现有的NBCD制造工艺需要提高效率,安全性和质量.
研究的目的:
- 审查在NBCD制造中选择Pharma 4.0技术的应用.
- 探索机器学习,in silico建模和3D打印在NBCDs上的影响.
- 为解决NBCD生产的监管考虑和未来前景.
主要方法:
- 文献审查侧重于制药4.0技术.
- 分析涉及特定NBCDs (脂质体,聚合物微粒,格拉提拉酸盐,铁碳水化合物复合物,纳米晶体) 的案例研究.
- 审查监管挑战和未来的技术整合.
主要成果:
- 机器学习,in silico建模和3D打印显示出改善NBCD制造的巨大潜力.
- 这些技术可以提高生产复杂药物配方的质量,安全性和效率.
- 数字双胞胎被认为是优化NBCD流程的有希望的未来方法.
结论:
- 制药4.0技术为克服NBCD制造中的复杂性提供了一条途径.
- 成功实施需要解决监管障碍,并采用创新的工具.
- 对数字双胞胎等技术的持续研究对于推进NBCD生产至关重要.
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