Technology Transfer and Process Development of Danicopan to Enable Process Validation

IF 3.1 3区化学 Q2 CHEMISTRY, APPLIED Organic Process Research & Development Pub Date : 2024-06-07 DOI:10.1021/acs.oprd.4c00067

Yangmu Chloe Liu, Suresh K. Tipparaju, Michael R. Tracey, Robert Carr, Anil Damarancha, Akihiro Hashimoto, Stephen Hubbs, Chad Keyes, John Lucas, Vidya Nandialath, Mark Stevens, Mareena Thottakara

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Abstract

Technology transfer and Current Good Manufacturing Practice (cGMP) manufacture of danicopan are described. During the acquisition of Achillion Pharmaceuticals (Achillion) by Alexion Pharmaceuticals (Alexion), a staged approach for technology transfer to Cambrex Charles City (CCC) was developed. The difference in Alexion’s and CCC’s approaches to process-validation-enabling studies as well as strategies to bridge the gap and meet both organizations’ expectations within a compressed timeline are discussed. The differences are best illustrated with an example step that was successfully validated concurrently at 45 and 210 kg scales in different work centers at the CCC facility to support multiple indications and programs for an advanced pharmaceutical intermediate. Key learnings are offered from the perspective of a sponsor organization and a contract manufacturer, highlighting a collaborative approach and partnership that allowed a successful execution with ambitious timelines while navigating the challenges of a global pandemic.

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达尼科潘的技术转让和工艺开发，以实现工艺验证

介绍了达尼可潘的技术转让和现行药品生产质量管理规范（cGMP）的生产情况。在 Alexion Pharmaceuticals（Alexion）收购 Achillion Pharmaceuticals（Achillion）期间，制定了向 Cambrex Charles City（CCC）进行技术转让的分阶段方法。本文讨论了 Alexion 和 CCC 在工艺验证研究方法上的差异，以及缩小差距并在压缩的时间内满足两家公司期望的策略。CCC 工厂的不同工作中心同时在 45 公斤和 210 公斤的规模下成功验证了一个步骤，以支持高级中间体制药的多种适应症和项目，这个例子最能说明其中的差异。从赞助商组织和合同制造商的角度提出了主要的经验教训，强调了合作方法和伙伴关系，从而在应对全球大流行病挑战的同时，在紧迫的时间内成功地执行了任务。

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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.