Session: Quality By Design in Drug Product Formulation, Design, and Process Development

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.