708 Quality By Design in Drug Product Formulation, Design, & Process Development I

Thursday, November 17, 2016: 12:30 PM - 3:00 PM
Continental 4 (Hilton San Francisco Union Square)
Description:
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.

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum
Co-Sponsor(s):
Pharmaceuticals (15B)

Chair:
True Rogers
Email: TLRogers@Dow.com

Co-Chair:
Lisa Lupton
Email: lisa.lupton@gilead.com


12:30 PM

1:20 PM
(708c) Secondary Drying Scale-up Methodology: Eliminating a Bottleneck with a Lean Development Approach
Tiago Porfirio, Pedro Valente, Ines Matos, Jorge Moreira, João Vicente, Márcio Temtem and Viriato Semião

2:10 PM
(708e) Production of Pharmaceutical Tablets By FDM 3D Printing
Matej Novak, Ales Zadrazil, Frantisek Stepanek and Pavel Kovacik

2:35 PM
(708h) Experimental Analysis of Pharmaceutical Twin-Screw Wet Granulation Using Hydrophilic and Hydrophobic Formulations
Maxim Verstraeten, Michael Ghijs, Daan Van Hauwermeiren, Ingmar Nopens, Thomas De Beer, Kai Lee, Neil Turnbull, Mary T. am Ende and Pankaj Doshi