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

• Published in: Organic 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
• Language: English
• Published: American Chemical Society 16.01.2015
• ISSN: 1083-6160; 1520-586X
• DOI: 10.1021/op5000978

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.