QbD Approach to Process Characterization and Quantitative Criticality Assessment of Process Parameters†

IF 3.1 3区化学 Q2 CHEMISTRY, APPLIED Organic Process Research & Development Pub Date : 2024-03-25 DOI:10.1021/acs.oprd.3c00356

Pankaj D. Rege*, Andreas Schuster*, Jens Lamerz, Christian Moessner, Wolfgang Göhring, Pirmin Hidber, Helmut Stahr, Oana Mihaela Andrei, Janine Burren, Alexandre Moesching, Daniel Coleman and Stefan Hildbrand,

引用次数: 0

Abstract

The quality-by-design (QbD) approach is widely utilized for developing and validating manufacturing processes for drug substances as well as drug products. This paper discusses the application of the risk-based QbD approach used at F. Hoffmann-La Roche Ltd. for development, optimization, and characterization of drug substance manufacturing processes for small molecules. It presents the evolution of the QbD concept into statistical thinking and development of a quantitative tool, namely, the impact ratio concept, for its successful implementation. The utilization of this approach is illustrated with a case study from the taselisib drug substance manufacturing process.

Abstract Image

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

工艺特征描述和工艺参数定量临界值评估的 QbD 方法†。

质量源于设计（QbD）方法被广泛用于开发和验证药物物质和药物产品的生产工艺。本文讨论了 F. Hoffmann-La Roche 有限公司基于风险的 QbD 方法在小分子药物生产工艺的开发、优化和表征中的应用。报告介绍了 QbD 概念向统计思维的演变，以及为成功实施 QbD 而开发的定量工具，即影响比概念。通过对他赛利西布（taselisib）药物生产过程的案例研究，说明了这种方法的应用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

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.