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End-to-End Continuous Manufacturing of Pharmaceuticals: Integrated Synthesis, Purification, and Final Dosage Formation

Authors


  • We thank Novartis International AG for funding and supplying our starting chemical intermediates. We would like to acknowledge the contribution of the pilot plant team, including Soubir Basak, Erin Bell, Stephen Born, Louis Buchbinder, Ellen Cappo, Corinne Carland, Alyssa N. D’Antonio, Joshua Dittrich, John Fisher, Megan A. Foley, Ryan Hartman, Devin Hershey, Rachael Hogan, Bowen Huo, Anjani Jha, Ashley S. King, Tushar Kulkarni, Timur Kurzej, Aaron Lamoureux, Paul S. Madenjian, Sean Ogden, Ketan Pimparkar, Joel Putnam, Anna Santiso, Jose C. Sepulveda, Min Su, Daniel Tam, Mengying Tao, Kristen Talbot, Christopher J. Testa, Justin Quon, Forrest Whitcher, and Aaron Wolfe.

Abstract

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A series of tubes: The continuous manufacture of a finished drug product starting from chemical intermediates is reported. The continuous pilot-scale plant used a novel route that incorporated many advantages of continuous-flow processes to produce active pharmaceutical ingredients and the drug product in one integrated system.

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