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首页> 外文期刊>ChemSusChem >Life Cycle Analysis within Pharmaceutical Process Optimization and Intensification: Case Study of Active Pharmaceutical Ingredient Production
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Life Cycle Analysis within Pharmaceutical Process Optimization and Intensification: Case Study of Active Pharmaceutical Ingredient Production

机译：药物过程优化和强化中的生命周期分析：活性药物成分生产案例研究

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摘要

As the demand for new drugs is rising, the pharmaceutical industry faces the quest of shortening development time, and thus, reducing the time to market. Environmental aspects typically still play a minor role within the early phase of process development. Nevertheless, it is highly promising to rethink, redesign, and optimize process strategies as early as possible in active pharmaceutical ingredient (API) process development, rather than later at the stage of already established processes. The study presented herein deals with a holistic life-cycle-based process optimization and intensification of a pharmaceutical production process targeting a low-volume, high-value API. Striving for process intensification by transfer from batch to continuous processing, as well as an alternative catalytic system, different process options are evaluated with regard to their environmental impact to identify bottlenecks and improvement potentials for further process development activities.
机译：随着对新药的需求正在上升，制药行业面临着缩短开发时间的追求，从而减少了市场的时间。 环境方面通常仍在过程开发的早期阶段中发挥着次要作用。 尽管如此，在活性药物成分（API）过程开发中尽早尽早获得工艺策略，而不是在已经建立的过程的阶段，这是高度承诺的。 本发明介绍了基于整体生命周期的过程优化和靶向低容量高值API的药物生产过程的增强。 通过从批次转移到连续处理的过程强化，以及替代催化系统，在环境影响方面评估不同的过程选项，以确定进一步的过程开发活动的瓶颈和改善潜力。

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