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Sustainability case studies on the use of continuous manufacturing in pharmaceutical production
Peer-reviewed journal | 06 Dec 2023 | Contributor(s):: Mark S. Kerr, Kevin P. Cole
Continuous processing is now commonly used in the manufacturing of fine chemicals including agrochemicals and pharmaceuticals. Datasets are now available, including some on environmental sustainability aspects, that enable more direct comparison between related batch and flow processes....
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Small-Volume Continuous Manufacturing of Merestinib. Part 1. Process Development and Demonstration
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Cole, KP, Reizman, BJHess, M, Groh, JM, Laurila, ME, Cope, RF, Campbell, BM, Forst, MB, Burt, JL, Maloney, TD, Johnson, MD, Mitchell, D, Polster, CS, Mitra, AW, Boukerche, M, Conder, EW, Braden, TM, Miller, RD, Heller, MR, Phillips, JL, Howell, JR
Development of a small volume continuous process that used a combination of batch and flow unit operations to manufacture the small molecule oncolytic candidate merestinib is described. Continuous processing was enabled following the identification and development of suitable chemical...
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Small-Volume Continuous Manufacturing of Merestinib. Part 2.Technology Transfer and cGMP Manufacturing
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Reizman, Brandon J., 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
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...