746 Product Quality Attribute Monitoring and Control in Drug Substance Manufacturing

Thursday, November 12, 2015: 3:15 PM - 5:45 PM
Ballroom B (Salt Palace Convention Center)

Ensuring drug substance production processes remain robust yet ensuring patient safety and drug efficacy is founded on understanding and control of both the process and the product. An understanding of the product requires knowledge of how the product interacts with human physiology leading to an understanding of critical quality attributes that supports efficacy and safety. This understanding is then translated into the process design and characterization of operating space. This session covers the identification and understanding of product quality attribute identification, characterization, and related process/product monitoring and control.

Pharmaceutical Discovery, Development and Manufacturing Forum
Product Design (12G), Pharmaceuticals (15B)
Gregory Frank Email: gfrank@amgen.com
Praveen Sharma Email: praveen.sharma@infi.com

3:15 PM
(746a) Hybrid Cell Culture Models for Efficient Process Development
Alessandro Butté, Michael Sokolov and Massimo Morbidelli

3:38 PM
(746b) The Impact of Glycation on Protein Color
Sharat Varma, Florian Krattenmacher, Natarajan Vijayasankaran, Steven Meier and Christopher Yu

4:24 PM
(746d) Application of Raman Spectroscopy in Cell Culture Process Development
Michael Sokolov, Daniel Karst, Vania Bertrand, Miroslav Soos, Massimo Morbidelli and Alessandro Butté

5:10 PM
(746f) Density Surrogate for Fine Tuning Dissolution of an Extended Release Tablet to Increase Manufacturing Process Robustness
Christopher Mancinelli, Jennifer Monaldi, Johnny Chowoe, Stelios C. Tsinontides, James Wright, Eda Ross Montgomery, Mani Sundararajan, Maury Winkler and Marty Shelton