Application of a Statistical Approach to the Process Development of Futibatinib by Employing Quality-by-Design Principles. Part 2: Development of Design Space for Impurities Using the Response Surface Methodology

IF 3.5 3区化学 Q2 CHEMISTRY, APPLIED

Organic Process Research & Development Pub Date : 2022-01-12 DOI:10.1021/acs.oprd.1c00146

Yasunori Abe*, Kosuke Emori

引用次数: 1

Abstract

This study aims to construct a design space of impurities for risk assessment based on the quality-by-design concept through focusing on the design of experiment and statistical analysis. First, we identify multiple regression equations for critical process parameters of impurities using face-centered composite design, which is a type of response surface methodology. Next, a design space is constructed by these prediction models for analyzing the risk of the impurities. Finally, this risk is evaluated by process understanding and control ranges in the construction of a control strategy. This study proves that the commercial manufacturing method is a robust process and futibatinib can be stably produced.

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采用质量设计原则的统计方法在福替替尼工艺开发中的应用。第2部分:利用响应面方法开发杂质的设计空间

本研究以实验设计和统计分析为重点，构建基于设计质量理念的杂质风险评估设计空间。首先，我们利用面心复合设计(一种响应面法)确定了杂质关键工艺参数的多元回归方程。然后，利用这些预测模型构建设计空间，分析杂质的风险。最后，在控制策略的构建中，通过过程理解和控制范围来评估这种风险。本研究证明，商业生产方法是一个稳健的过程，可以稳定地生产福替替尼。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Organic Process Research & Development 化学-应用化学

CiteScore

6.90

自引率

14.70%

发文量

251

审稿时长

2 months

期刊介绍： The journal Organic Process Research & Development serves as a communication tool between industrial chemists and chemists working in universities and research institutes. As such, it reports original work from the broad field of industrial process chemistry but also presents academic results that are relevant, or potentially relevant, to industrial applications. Process chemistry is the science that enables the safe, environmentally benign and ultimately economical manufacturing of organic compounds that are required in larger amounts to help address the needs of society. Consequently, the Journal encompasses every aspect of organic chemistry, including all aspects of catalysis, synthetic methodology development and synthetic strategy exploration, but also includes aspects from analytical and solid-state chemistry and chemical engineering, such as work-up tools，process safety, or flow-chemistry. The goal of development and optimization of chemical reactions and processes is their transfer to a larger scale; original work describing such studies and the actual implementation on scale is highly relevant to the journal. However, studies on new developments from either industry, research institutes or academia that have not yet been demonstrated on scale, but where an industrial utility can be expected and where the study has addressed important prerequisites for a scale-up and has given confidence into the reliability and practicality of the chemistry, also serve the mission of OPR&D as a communication tool between the different contributors to the field.