使用Pharmapy进行动态,端到端的最佳药品竞选制造的技术经济分析
Daniel Casas-Orozco1, Daniel Laky1, Vivian Wang2
1Davidson School of Chemical Engineering, Purdue University, West Lafayette, IN 47906, USA.
概括
对于小规模的制药制造,结合连续反应器和半批量蒸发的混合方法是最具成本效益的. 这个数字框架有助于比较批量,混合和连续工艺配置,用于生产活性药物成分.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 化学工程是化学工程的重要组成部分.
- 工艺系统工程 工艺系统工程
背景情况:
- 越来越多的制药行业对从批量制造向连续制造过渡的兴趣.
- 需要数字框架来系统地比较流程配置以提高效率.
- 由于竞选时间,小规模制造对连续流程提出了独特的挑战.
研究的目的:
- 评估批量,混合和连续制造配置的技术和经济可行性,用于小规模生产活性药物成分 (API).
- 分析生产活动,考虑连续设备的启动效应.
- 通过数字评估来确定最佳的端到端流程配置.
主要方法:
- 批量,混合和连续制造工艺配置的比较分析.
- 对小型API生产的经济和技术可行性评估.
- 制作活动的建模和模拟,包括启动效应.
主要成果:
- 混合运行模式,利用连续反应器和半批蒸发,成为中等和大型年度生产目标最有吸引力的配置.
- 由于连续结晶的延长稳定时间和闪光蒸发的热力学限制,发现连续运行成本更高.
- 批量制造仍然是一个可行的选择,特别是对于较小的生产规模.
结论:
- 对工艺配置进行系统的数字评估,有助于确定最佳的制造策略.
- 混合制造为小型API生产提供了令人信服的效率和成本效益平衡.
- 了解启动效应和设备限制对于成功实施连续和混合过程至关重要.
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