Troubleshooting and Performance Recovery of a Pharmaceutical Manufacturing Process Involving a Novel Asymmetric Hydrogenation and a Chiral Crystallization
Osama Sudah1, Aaron Moment2, Carlos Burgos3, Cindy Starbuck4, Andrew Clausen4, Mahmoud Kaba5, Carlos Sanchez4, Ryan Adorno3, Mabel Suarez6, Alvin Negron3, Luis Sierra4 and Ramon Huertas7, (1)Chemical Process Development & Commercialization, Merck & Co., Inc., RY818-C314, P.O Box 2000, Rahway, NJ 07065, (2)Merck & Co., Inc., Rahway, NJ, (3)Merck & Co., Inc., Barceloneta, PR, (4)Merck & Co., Inc., Rahway, NJ, (5)Merck & Co. Inc, Barceloneta, PR, (6)Merck & Co., Inc., Barceloneta, PR, (7)Merck & Co., Inc., PR |
Control of a Membrane Separation Process by UV / Vis P.a.T
James Marek, Eric Stoner and James Schilling, GPRD Process R&D, Abbott Labs, 1401 Sheridan Road, R13-3, North Chicago, IL 60064 |
Expedite Development and Commercialization of Pharmaceuticals with Process Modeling and Scheduling Tools
Demetri Petrides, INTELLIGEN, Inc., 2326 Morse Avenue, Scotch Plains, NJ 07076 and Charles Siletti, INTELLIGEN, INC., 700 Walton Ave., Mount Laurel, NJ 08054 |
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Modeling Based Approach towards on-Scale Implementation of a Methanethiol Emitting Reaction
Brenda Remy, Shawn Brueggemeier, Olav Lyngberg, D Lin, Alex Marchut and L Hobson, Bristol Myers Squibb, New Brunswick, NJ 08902 |
Applications of Mass Spectrometry for Monitoring Gaseous Streams during Processing
John P. Gardner1, Jacob R. Remacle1, Steven J. Doherty2, Daniel J. Creeden2, Kevin D. Seibert3, Zhonghui Wan4, Amanda L. Mc Daniel4, John P. Schafer1 and Gary A. Richardson1, (1)API Operations Engineering, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285-4816, (2)PAT, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285-4816, (3)Development Engineering, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285-4816, (4)Chemical Product Research and Development, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285-4816 |
A Quality by Design Qbd Approach for Pharmaceutical Capsule Filling Unit Operation: Identifying Critical Process Variables and Detecting Possible Interactions
Huiquan Wu1, Lin Xie2, Meiyu Shen3, Mansoor A. Khan4, Larry Augsburger2 and Stephen W. Hoag2, (1)CDER, FDA, 10903 New Hampshire Ave, White Oak LS 64, Room 1080, HFD-940, Silver Spring, MD 20993, (2)School of Pharmacy, University of Maryland, (3)CDER, FDA, 10903 New Hampshire Ave, White Oak Building 22, Room 5209, Silver Spring, MD 20993, (4)CDER, FDA, 10903 New Hampshire Ave, White Oak LS 64, Room 1070, HFD-940, Silver Spring, MD 20993 |
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