Near Infrared Spectroscopy In-Depth Focus 2014

• Near infrared light spectroscopy: Applicability and new developments
  (Authors: Otto Scheibelhofer, PhD student, Continuous Processes and Quality Control, Research Center Pharmaceutical Engineering / Stephan Sacher, Area Manager, Process Engineering, Research Center Pharmaceutical Engineering / Johannes G. Khinast, Head of Institute, Institute for Process and Particle Engineering, Graz University of Technology)
  Due to a broad range of applications, near infrared spectroscopy is the analytical tool of choice for diverse processes and is often used in the industry. Its potential is increasingly exploited, with the ultimate promise of 100 per cent inspection of drug products and real-time release. This paper presents a brief overview of limitations and recent applications in the pharmaceutical industry…
• Near infrared spectroscopy: in-line biopharmaceutical Chinese Hamster Ovary cell culture monitoring
  (Authors: Matthieu Clavaud and Yves Roggo, F. Hoffmann-La Roche Ltd)
  Near infrared (NIR) spectroscopy has been used for several years as a non-destructive tool both for Process Analytical Technology (PAT) applications and in quality control laboratories for release and stability analysis. Combined with chemometric tools, NIR enables the enhancement and the control of process knowledge for solid, liquid and biopharmaceutical forms. Advances in instrumentation and data analysis allow for the setting up of complex experiments and the acquisition of data which would otherwise be unavailable with conventional wetchemistry analyses. In this study, NIR and chemometrics have been successfully applied for controlling and monitoring Chinese Hamster Ovary (CHO) cell culture. NIR can be used for detection of out of trend batches and to quantify in-line critical process attributes like protein content and cell density…