Kaiser hosts a series of complimentary webinar presentations which demonstrate Raman Spectroscopy-based solutions. Hear from real customers and their success stories using Kaiser Raman analyzers and instruments. Examples of Research Raman, Analytical Raman, Process Raman, In Situ Raman, Industrial Raman, Remote Raman, and Raman Imaging and Microscopy are available during these sessions. We invite you to register for an upcoming webinar of interest, or view previous archives. Kaiser Webinar Archives are available in the sidebar -- see what you've been missing!
Real Customers - Their Applications, Raman Solutions
Utilization of Raman Spectroscopy for Primary and Secondary Pharmaceutical Development
Process Analytical Technology (PAT) has been widely implemented across the pharmaceutical industry for understanding and controlling drug manufacturing processes, with an increasing number of applications using Raman spectroscopy. Some applications of Raman spectroscopy used for primary and secondary manufacturing of pharmaceutical products will be discussed.
In primary manufacturing, in situ Raman spectroscopy has been used as a method to determine reaction end-point during pilot plant scale manufacture. Using Raman spectroscopy to minimize levels of starting material at the reaction end‐point was important due to its downstream impact on a drug substance’s Critical Quality Attribute (CQA). Furthermore, the reaction required the use of heterogeneous base, and therefore the time to reach reaction completion could be scale dependent, owing to differences in reactor geometry and mixing characteristics. There are an increasing number of instances where continuous primary manufactures are required; work has taken place to implement PAT technologies for process monitoring. An example implementing Raman spectroscopy into a continuous flow process to measure and optimize the reaction progress is described.
In secondary manufacturing, a case utilized transmission Raman spectroscopy for the determination of Uniformity of Dosage Unit (UoDU) for whole tablets during tablet manufacturing at scale‐up. Raman spectroscopy was used as an alternative to near infrared spectroscopy (NIR) to allow greater selectivity which could aid calibration. Transmission Raman spectroscopy also gives an increased sampling volume compared with backscatter Raman spectroscopy making it ideal for non‐destructive quantitative analysis of uniformity of content in pharmaceuticals. Due to these advantages transmission Raman measurements have been successfully applied in several drug development projects.
AIR DATE: May 14, 2015
Name: Dr. Allyson McIntyre
Title: Senior Scientist, PAT Specialist in Global Chemical Development