Small-Volume Continuous Manufacturing of Merestinib. Part 2. Technology Transfer and cGMP Manufacturing

• Published in: Organic process research & development Vol. 23; no. 5; pp. 870 - 881
• Main Authors: Reizman, Brandon J, Cole, Kevin P, Hess, Molly, Burt, Justin L, Maloney, Todd D, Johnson, Martin D, Laurila, Michael E, Cope, Richard F, Luciani, Carla V, Buser, Jonas Y, Campbell, Bradley M, Forst, Mindy B, Mitchell, David, Braden, Timothy M, Lippelt, Christopher K, Boukerche, Moussa, Starkey, Derek R, Miller, Richard D, Chen, Jing, Sun, Baoquan, Kwok, Martin, Zhang, Xin, Tadayon, Sam, Huang, Ping
• Format: Journal Article
• Language: English
• Published: American Chemical Society 17.05.2019
• Subjects: scale-up; flow-NMR; continuous processing; continuous crystallization; small volume continuous; flow chemistry

Technology transfer of a small volume continuous (SVC) process and Current Good Manufacturing Practices (cGMP) manufacturing of merestinib are described. A hybrid batch-SVC campaign was completed at a contract manufacturing organization under cGMP. The decision process by which unit operations were...