The application of Quality by Design principles is beginning to be well established in the pharmaceutical industry. In particular, the demonstration of the science and risk-based approaches being applied to specific subsets of the drug product design or processing has been discussed intensively during the past several years. Therefore, it is now time to widen the scope of QbD across multiple unit operations, including important aspects of the drug substance. This session invites presentations in which drug products have been designed and developed demonstrating a holistic QbD approach. Papers concerning small and large molecules, including biologics, are being considered. The goal of this session is to demonstrate QbD being applied across multiple unit operations and integrating aspects of the API.

Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture