Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes

Abstract

33Within the Process Analytical Technology (PAT) framework, it is of utmost importance to obtain 34 critical process and formulation information during pharmaceutical processing. Process analyzers are 35 the essential PAT tools for real-time process monitoring and control as they supply the data from 36 which relevant process and product information and conclusions are to be extracted.

Raman spectroscopy and multivariate analysis for the rapid discrimination between native-like and non-native states in freeze-dried protein formulations

“…real-time) analysis results, while being information-rich and robust in the presence of interferents. Most of them rely on spectroscopic techniques combined with multivariate analysis (MVA) [2][3][4]. As they usually lack the conventional delay inherent to the standard analytical techniques for sampling, sample preparation, analysis, data extraction and interpretation, not only the laboratory work, time and costs may be reduced, but they may also allow decision making in real-time.…”

Development and validation of an at-line fast and non-destructive Raman spectroscopic method for the quantification of multiple components in liquid detergent compositions

“…Thus, advanced manufacturing practices are being implemented in the pharmaceutical, chemical, biotechnological and food industry, enhancing process efficiency and guaranteeing product quality [3][4][5][6][7][8][9]. The consumer goods industry, on the contrary, has been slow at adapting this PAT approach.…”

“…The list of Raman applications in the pharmaceutical industry seems endless and the use in other industries (e.g. food, forensics, plastic sorting and recycling…) has been growing extensively in the past few years; but again, the consumer goods field is behind on this [3], [4], [10]- [18].…”

In-line ATR-UV and Raman Spectroscopy for Monitoring API Dissolution Process During Liquid-Filled Soft-Gelatin Capsule Manufacturing

“…With the increasing acceptance of QBD/PAT initiatives by the pharmaceutical industry, real-time analytical tools are more frequently used for improving process understanding, implementing process control, and product release. For example, NIR spectroscopy has been widely used for online/at-line analysis of solid dosage drug product in manufacturing (8)(9)(10)(11). A number of publications have shown the use of Raman for in-process monitoring and control during both drug substance and product manufacturing (8,(12)(13)(14).…”

“…For example, NIR spectroscopy has been widely used for online/at-line analysis of solid dosage drug product in manufacturing (8)(9)(10)(11). A number of publications have shown the use of Raman for in-process monitoring and control during both drug substance and product manufacturing (8,(12)(13)(14). However, to our knowledge, no applications have been reported on using in-line spectroscopy tools to support manufacturing of SGC products.…”