742 Product Quality Attribute Monitoring and Control in Drug Product Manufacturing

Thursday, November 17, 2016: 3:15 PM - 5:45 PM
Continental 4 (Hilton San Francisco Union Square)
Robustness of drug product formulation and processing helps assure patient safety and drug efficacy being founded on thorough understanding and control. An understanding of the product requires knowledge of how the product performs in vivo, thus translating that knowledge of critical quality attributes that support efficacy and safety. This understanding is then translated into the drug product design and characterization of operating space. This session covers the drug product quality attribute identification, characterization, and related process/product monitoring and control strategy.

Pharmaceutical Discovery, Development and Manufacturing Forum
Product Design (12G), Pharmaceuticals (15B)

Thomas De Beer
Email: thomas.debeer@ugent.be

Suhas Shelukar
Email: sshelukar@shire.com

3:37 PM
(742b) Using Optical Coherence Tomography (OCT) to Analyze in Real-Time the Tablet Coating Variability of a Continuous Drum Coating Process
Patrick R. Wahl, Manuel Zettl, Stephan Sacher, Rainer Bastian, Thomas Fränkel, Johannes G. Khinast and Matthias Wolfgang

3:59 PM

4:21 PM
(742d) Raman Spectroscopy- Towards the Prediction of Quality Attributes and Application in Cell Culture Process Development
Fabian Feidl, Michael Sokolov, Ines Da Silva Costa, Jean-Marc Bielser, Jonathan Souquet, Hervé Broly, Carsten Uerpmann, Massimo Morbidelli and Alessandro Butté

4:43 PM

5:05 PM
(742f) 3D Raman Spectroscopy – a Method for Mapping Ingredient Distribution throughout a Tablet Volume
Savitha Panikar, Wei Meng, Pallavi Pawar, Sarang Oka, Rudy Hofmeister and Fernando Muzzio

5:27 PM
(742g) Real-Time Monitoring and Modeling of Milling in a Continuous Tableting Line Via Dry Granulation
Mariana Moreno, Qinglin Su, Zoltan K. Nagy and Gintaras Reklaitis