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Mini-Monoplant Technology for Pharmaceutical Manufacturing
Organic Process Research & Development ( IF 3.1 ) Pub Date : 2020-08-26 , DOI: 10.1021/acs.oprd.0c00207 Brendon J. Doyle 1 , Petteri Elsner 2 , Bernhard Gutmann 2 , Olivier Hannaerts 2 , Christof Aellig 2 , Arturo Macchi 1 , Dominique M. Roberge 2
Organic Process Research & Development ( IF 3.1 ) Pub Date : 2020-08-26 , DOI: 10.1021/acs.oprd.0c00207 Brendon J. Doyle 1 , Petteri Elsner 2 , Bernhard Gutmann 2 , Olivier Hannaerts 2 , Christof Aellig 2 , Arturo Macchi 1 , Dominique M. Roberge 2
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Pharmaceutical production has historically relied on multipurpose batch vessels in order to produce material through scheduled production campaigns. Although this method is flexible, it is becoming less effective in addressing the changing landscape of pharmaceutical production, where more complex and potent molecules are required to be produced more rapidly and can have fluctuations in their demand. This article describes a method for developing intensified and dedicated pharmaceutical processes, known as mini-monoplants. Key value-generating aspects are described at each stage of development, from lab-based development of best-in-class processes to factory-based development for an accelerated time to market and finally to mini-monoplant technology for production at commercial scale.
中文翻译：
制药业的微型单植物技术
从历史上看，药品生产依靠多用途批次容器来通过计划的生产活动生产原料。尽管此方法具有灵活性，但在应对不断变化的制药业形势方面效果不佳，因为在这种情况下，需要更快速地生产更复杂和有效的分子，并且其需求可能会出现波动。本文介绍了一种开发强化的专用制药工艺的方法，称为微型单株植物。在开发的每个阶段都描述了关键的价值创造方面，从基于实验室的最佳流程开发到工厂开发，以加快上市时间，最后到微型单工厂技术以商业规模生产。
更新日期：2020-10-17
中文翻译：
制药业的微型单植物技术
从历史上看，药品生产依靠多用途批次容器来通过计划的生产活动生产原料。尽管此方法具有灵活性，但在应对不断变化的制药业形势方面效果不佳，因为在这种情况下，需要更快速地生产更复杂和有效的分子，并且其需求可能会出现波动。本文介绍了一种开发强化的专用制药工艺的方法，称为微型单株植物。在开发的每个阶段都描述了关键的价值创造方面，从基于实验室的最佳流程开发到工厂开发，以加快上市时间，最后到微型单工厂技术以商业规模生产。
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