767 Quality By Design in Drug Product Formulation, Design, & Process Development II

Friday, November 18, 2016: 8:30 AM - 11:00 AM
Continental 4 (Hilton San Francisco Union Square)
The intent of this session is to provide an open forum to explore how Quality by Design (QbD) is being implemented throughout the pharmaceutical industry. Scientists are increasingly integrating QbD principles and practices to produce more robust, higher quality drug products that are safer and more effective. QbD principles can be utilized at various stages of the manufacturing process, from understanding the impacts of incoming API and excipient raw material attributes, through blending and intermediate unit operations, to dosage form finalization. QbD is just as critical for implementation of established technologies, such as spray drying, granulation, direct compression, or capsule filling, to relatively new technologies, such as hot-melt extrusion, continuous granulation, or 3-D printing. Scientists developing small-molecule or macromolecular drug products and utilizing QbD principles to design robust processes and products are encouraged to submit abstracts.

Pharmaceutical Discovery, Development and Manufacturing Forum
Pharmaceuticals (15B)

Zhigang Sun
Email: zhigang.sun@fda.hhs.gov

True Rogers
Email: TLRogers@Dow.com

8:30 AM
(767a) Feedforward Control of Continuous Pharmaceutical Manufacturing Process
Ravendra Singh, Glinka Cathy Pereira, Nikita Soni, Andrés D. Román-Ospino, Marianthi Ierapetritou and Rohit Ramachandran

9:36 AM
(767d) HPMC Cloud Point: Exploring Hydroxypropylmethyl Cellulose Behavior in Pharmaceutical Formulations
Maryam Mohammadpour, Brian Krins, Mary Ellen Crowley, Gavin Walker and Abina Crean

10:20 AM
(767f) Utilization of Quality By Design Principles to Define Formulation Best Practices for a Direct Compression Excipient
Kathryn Hewlett, True Rogers,, Karen Balwinski, Jaime Curtis-Fisk, Robert Schmitt and Shrikant Khot