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欧洲制药行业的化学工艺开发——来自行业科学家的见解与观点

Chemical Process Development in the Pharmaceutical Industry in Europe-Insights and Perspectives from Industry Scientists.

作者信息

Krueger Joachim, Dieskau André P, Hassfeld Jorma, Gries Joerg, Block Oliver, Weinmann Hilmar, Kaufmann Daniel, Hildbrand Stefan, Kraft Volker, Moeckel Robert, Dehli Juan R, Scholz Ulrich, Nising Carl Friedrich

机构信息

Pharmaceuticals CMC & Technology, Bayer AG, D-42096, Wuppertal, Germany.

Global CMC Development, Merck Healthcare KGaA, D-64293, Darmstadt, Germany.

出版信息

Angew Chem Int Ed Engl. 2025 May;64(19):e202420719. doi: 10.1002/anie.202420719. Epub 2025 Mar 27.

Abstract

Chemical process development is a critical component in the development process for active pharmaceutical ingredients (APIs). With interfaces to drug discovery and API manufacturing, chemical process development activities must deliver scalable, safe, cost-efficient, sustainable, and reliable processes for novel as well as marketed APIs. Despite its importance for the pharmaceutical industry and society, the domain of chemical process development, together with its advances and challenges, is often not well known to nonpractitioners. As industry scientists, we provide a scientific perspective on the state of affairs in chemical process development, which we believe will be of value to a broader audience, including academic researchers, students, and professionals from related fields.

摘要

化学工艺开发是活性药物成分(API)开发过程中的关键组成部分。由于与药物发现和API制造存在接口,化学工艺开发活动必须为新型以及已上市的API提供可扩展、安全、具有成本效益、可持续且可靠的工艺。尽管化学工艺开发领域对制药行业和社会至关重要,但其进展和挑战对于非从业者来说往往并不为人熟知。作为行业科学家,我们提供了关于化学工艺开发现状的科学视角,我们相信这将对更广泛的受众有价值,包括学术研究人员、学生以及相关领域的专业人士。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/295b/12051753/1774df4397b6/ANIE-64-e202420719-g008.jpg

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