183 Application of Quality by Design in Drug Product Formulation Design & Process Development

Monday, November 9, 2015: 3:15 PM - 5:45 PM
Ballroom B (Salt Palace Convention Center)

Pharmaceutical Quality by design (QbD) is a systematic, risk-based, scientific approach for product design and process development to ensure predefined drug product quality. It requires a thorough understanding of critical formulation attributes and critical process parameters as well as impacts of their variations on the final drug product quality. The goals of implementing pharmaceutical QbD are to reduce product variability and defects, maximize safety and efficacy for the patient, increase product development and manufacturing efficiencies, and enhance post-approval change management. This session invites presentations to demonstrate the application of QbD principles during formulation design and process development of a drug product. Papers concerning small and large molecules, including biologics, are being considered. It is intended to provide an open forum to explore how to facilitate QbD implementation in pharmaceutical industry.

Pharmaceutical Discovery, Development and Manufacturing Forum
Pharmaceuticals (15B)
Zhigang Sun Email: zhigang.sun@fda.hhs.gov
True Rogers Email: TLRogers@Dow.com

3:36 PM
(183b) Predicting Roller Compaction Process Capability
Jacob Albrecht, Vishwas Nesarikar, Jose Tabora, Jennifer Walsh, G. Scott Jones, John R. Crison and Ronald Behling

3:57 PM
(183c) Impact of API Properties and Excipient Source on the Process and Performance of a Typical High Shear Wet Granulation Formulation
Junshu Zhao, Preetanshu Pandey, Shasad Sharif, Sherif Badawy, Dilbir Bindra and Arturo Marin

5:00 PM
(183f) An Optimization Framework to Combine Design Space Maximization with Design of Experiments
Qi Chen, Remigijus Paulavicius, Salvador García-Muñoz and Claire S. Adjiman