Process Development and Control with Recent New FBRM, PVM, and IR

Process analytical technologies (PATs) have played an important role in process development and optimization throughout the pharmaceutical industry. Recent new PATs, including in-process video microscopy (PVM), a new generation of focused-beam reflectance measurement (FBRM), miniature process IR spe...

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Published inOrganic process research & development Vol. 19; no. 1; pp. 227 - 235
Main Authors Zhou, George, Moment, Aaron, Cuff, James, Schafer, Wes, Orella, Charles, Sirota, Eric, Gong, Xiaoyi, Welch, Christopher
Format Journal Article
LanguageEnglish
Published American Chemical Society 16.01.2015
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Abstract Process analytical technologies (PATs) have played an important role in process development and optimization throughout the pharmaceutical industry. Recent new PATs, including in-process video microscopy (PVM), a new generation of focused-beam reflectance measurement (FBRM), miniature process IR spectroscopy, and a flow IR sensor, have been evaluated, demonstrated, and utilized in the process development of many drug substances. First, PVM has filled a technical gap by providing the capability to study morphology for particle engineering by visualizing particles in real time without compromising the integrity of sample. Second, the new FBRM G series has closed gaps associated with the old S series with respect to probe fouling, bearing reliability, data analysis, and software integration. Third, a miniaturized process IR analyzer has brought forth the benefits of increased robustness, enhanced performance, improved usability, and ease of use, especially at scale-up. Finally, a miniaturized flow IR sensor has provided process flow chemistry development with a smaller, faster-performing, less expensive analytical tool.
AbstractList Process analytical technologies (PATs) have played an important role in process development and optimization throughout the pharmaceutical industry. Recent new PATs, including in-process video microscopy (PVM), a new generation of focused-beam reflectance measurement (FBRM), miniature process IR spectroscopy, and a flow IR sensor, have been evaluated, demonstrated, and utilized in the process development of many drug substances. First, PVM has filled a technical gap by providing the capability to study morphology for particle engineering by visualizing particles in real time without compromising the integrity of sample. Second, the new FBRM G series has closed gaps associated with the old S series with respect to probe fouling, bearing reliability, data analysis, and software integration. Third, a miniaturized process IR analyzer has brought forth the benefits of increased robustness, enhanced performance, improved usability, and ease of use, especially at scale-up. Finally, a miniaturized flow IR sensor has provided process flow chemistry development with a smaller, faster-performing, less expensive analytical tool.
Author Gong, Xiaoyi
Welch, Christopher
Zhou, George
Moment, Aaron
Schafer, Wes
Cuff, James
Orella, Charles
Sirota, Eric
AuthorAffiliation Merck Sharp & Dohme Corporation
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