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 and Mareena Thottakara,
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Technology Transfer and Process Development of Danicopan to Enable Process Validation
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.
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.