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Industrial Case Studies Demonstrating Applicability of ICH M7 Control Options 3 and 4 for Nitrosamine Control Urquhart, Michael W.; Burns, Michael J.; Bernardoni, Frank; Clark, Hugh F.; Crochard, Jean-Philippe; De Benedetti, Alessandro; Dirat, Olivier; Fennell, Jared W.; Gall, Malcolm A. Y.; Galli, Marzia; Hildbrand, Stefan; Kallemeyn, Jeffrey M.; Kuhl, Nadine; Mack, Daniel J.; Moessner, Christian; Pascoe, David D.; Pozzoli, Alessandro; Risch, Philippe; Roberts, Alastair J.; Teasdale, Andrew; Thiel, Oliver R.; Tomlin, Paula; Whitehead, Andrew 分享 收藏
Leveraging ICH M7 Control Options 3 and 4: Discussion and Clarification Using Industrial Case Studies Urquhart, Michael W.; Burns, Michael J.; Clark, Hugh F.; Crochard, Jean-Philippe; Dirat, Olivier; Hildbrand, Stefan; Moessner, Christian; Pascoe, David D.; Roberts, Alastair J.; Teasdale, Andrew; Thiel, Oliver R. 分享 收藏
PAT-Enabled Automated Feedforward Control: An Application to the Continuous Manufacture of Apremilast Hsieh, Hsiao-Wu; Griffin, Daniel J.; Nambiar, Anirudh M. K.; Sarkar, Nandini; Ismail, Hamza Youssef; Saigal, Kartik; Shen, Dongying Erin; Goudas-Salomon, Nicole; Wimalasinghe, Rasangi; Zeng, Alicia; Thiel, Oliver R.; Beaver, Matthew G. 分享 收藏
A Continuous Process for Manufacturing Apremilast. Part I: Process Development and Intensification by Utilizing Flow Chemistry Principles Hsieh, Hsiao-Wu; Cohen, Carolyn M.; Griffin, Daniel J.; Ananthoji, Padmini; Avci, Nadide Hazal; Brown, Derek B.; Ericson, Ari; Fostinis, James D.; Irfan, Muhammad; Langille, Neil; Lovette, Michael A.; Murray, James I.; Spada, Simone; Thiel, Oliver R.; Aiello, Frankie; Daou, Joseph; Goudas-Salomon, Nicole; Pan, Ende; Sarkar, Nandini; Wimalasinghe, Rasangi; Wu, Zufan Steven; Zeng, Alicia; Beaver, Matthew G. 分享 收藏
Development of a Commercial Manufacturing Process for Sotorasib, a First-in-Class KRASG12C Inhibitor Zhang, Liang; Griffin, Daniel J.; Beaver, Matthew G.; Blue, Laura E.; Borths, Christopher J.; Brown, Derek B.; Caille, Seb; Chen, Ying; Cherney, Alan H.; Cochran, Brian M.; Colyer, John T.; Corbett, Michael T.; Correll, Tiffany L.; Crockett, Richard D.; Dai, Xi-Jie; Dornan, Peter K.; Farrell, Robert P.; Hedley, Simon J.; Hsieh, Hsiao-Wu; Huang, Liang; Huggins, Seth; Liu, Min; Lovette, Michael A.; Quasdorf, Kyle; Powazinik, William; Reifman, Jonathan; Robinson, Jo Anna; Sangodkar, Rahul P.; Sharma, Sonika; Kumar, Srividya Sharvan; Smith, Austin G.; St-Pierre, Gabrielle; Tedrow, Jason S.; Thiel, Oliver R.; Truong, Jonathan V.; Walker, Shawn D.; Wei, Carolyn S.; Wilsily, Ashraf; Xie, Yong; Yang, Ning; Parsons, Andrew T. 分享 收藏
Synthesis of Substituted Pyridines via Formal (3+3) Cycloaddition of Enamines with Unsaturated Aldehydes and Ketones Dai, Xi-Jie; Krolikowski, Paul; Murray, James I.; Wei, Carolyn S.; Dornan, Peter K.; Rotheli, Andreas R.; Caille, Seb; Thiel, Oliver R.; Smith, Austin G.; Parsons, Andrew T. 分享 收藏
Accelerated Development of a Scalable Ring-Closing Metathesis to Manufacture AMG 176 Using a Combined High-Throughput Experimentation and Computational Modeling Approach St-Pierre, Gabrielle; Cherney, Alan H.; Chen, Wencan; Dong, Xiaofei; Dornan, Peter K.; Griffin, Daniel J.; Houk, K. N.; Lin, Janice B.; Osgood, Stephen; Elipe, Maria V. Silva; Timmons, Heath C.; Xie, Yong; Tedrow, Jason S.; Thiel, Oliver R.; Smith, Austin G. 分享 收藏
Development of a Factory Process for Omecamtiv Mecarbil, a Novel Cardiac Myosin Activator Caille, Seb; Allgeier, Alan M.; Bernard, Charles; Correll, Tiffany L.; Cosbie, Andrew; Crockett, Richard D.; Cui, Sheng; Faul, Margaret M.; Hansen, Karl B.; Huggins, Seth; Langille, Neil; Mennen, Steven M.; Morgan, Bradley P.; Morrison, Henry; Muci, Alexander; Nagapudi, Karthik; Quasdorf, Kyle; Ranganathan, Krishnakumar; Roosen, Philipp; Shi, Xianqing; Thiel, Oliver R.; Wang, Fang; Tvetan, Justin T.; Woo, Jacqueline C. S.; Wu, Steven; Walker, Shawn D. 分享 收藏
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Facile Modulation of Antibody Fucosylation with Small Molecule Fucostatin Inhibitors and Cocrystal Structure with GDP-Mannose 4,6-Dehydratase Allen, John G.; Mujacic, Mirna; Frohn, Michael J.; Pickrell, Alex J.; Kodama, Paul; Baga, Dhanashri; San Miguel, Tisha; Sickmier, E. Allen; Osgood, Steve; Swietlow, Aleksander; Li, Vivian; Jordan, John B.; Kim, Ki-Won; Rousseau, Anne-Marie C.; Kirn, Yong-Jae; Caille, Seb; Achmatowicz, Mike; Thiel, Oliver; Fotsch, Christopher H.; Reddy, Pranhitha; McCarter, John D. 分享 收藏
Telescoped Process to Manufacture 6,6,6-Trifluorofucose via Diastereoselective Transfer Hydrogenation: Scalable Access to an Inhibitor of Fucosylation Utilized in Monoclonal Antibody Production Achmatowicz, Michal M.; Allen, John G.; Bio, Matthew M.; Bartberger, Michael D.; Borths, Christopher J.; Colyer, John T.; Crockett, Richard D.; Hwang, Tsang-Lin; Koek, Jan. N.; Osgood, Stephen A.; Roberts, Scott W.; Swietlow, Aleksander; Thiel, Oliver R.; Caille, Seb 分享 收藏
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Oxopyrido[2,3-d]pyrimidines as Covalent L858R/T790M Mutant Selective Epidermal Growth Factor Receptor (EGFR) Inhibitors Wurz, Ryan P.; Pettus, Liping H.; Ashton, Kate; Brown, James; Chen, Jian Jeffrey; Herberich, Brad; Hong, Fang-Tsao; Hu-Harrington, Essa; Nguyen, Tom; St Jean, David J., Jr.; Tadesse, Seifu; Bauer, David; Kubryk, Michele; Zhan, Jinghui; Cooke, Keegan; Mitchell, Petia; Andrews, Kristin L.; Hsieh, Faye; Hickman, Dean; Kalyanaraman, Nataraj; Wu, Tian; Reid, Darren L.; Lobenhofer, Edward K.; Andrews, Dina A.; Everds, Nancy; Guzman, Roberto; Parsons, Andrew T.; Hedley, Simon J.; Tedrow, Jason; Thiel, Oliver R.; Potter, Matthew; Radinsky, Robert; Beltran, Pedro J.; Tasker, Andrew S. 分享 收藏
Selection of a Suitable Physical Form and Development of a Crystallization Process for a PDE10A Inhibitor Exhibiting Enantiotropic Polymorphism Kiang, Y. -H.; Bercot, Eric A.; Wu, Qiong; Liu, Jodi; Milburn, Robert R.; Cohen, Dawn E.; Borths, Christopher J.; Saw, Robert E.; Staples, Richard J.; Davis, Carl; Thiel, Oliver R. 分享 收藏
AMG 580: A Novel Small Molecule Phosphodiesterase 10A (PDE10A) Positron Emission Tomography Tracer Chen, Hang; Lester-Zeiner, Dianna; Shi, Jianxia; Miller, Silke; Glaus, Charlie; Hu, Essa; Chen, Ning; Able, Jessica; Biorn, Christopher; Wong, Jamie; Ma, Ji; Michelsen, Klaus; Della Puppa, Geraldine Hill; Kazules, Tim; Dou, Hui Hannah; Talreja, Santosh; Zhao, Xiaoning; Chen, Ada; Rumfelt, Shannon; Kunz, Roxanne K.; Ye, Hu; Thiel, Oliver R.; Williamson, Toni; Davis, Carl; Porter, Amy; Immke, David; Allen, Jennifer R.; Treanor, James 分享 收藏
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