Session: Application of Quality By Design in Drug Product Process Development I

The importance of Quality-by-Design (QbD) for product process development has become increasingly apparent in the pharmaceutical industry, as this methodology promotes scientific and risk-based understanding during drug product development and scale-up. QbD approaches enable better product robustness and improved process control, the latter providing the potential to facilitate transition from batch to continuous manufacture. We invite submissions that demonstrate the application of QbD principles during process development of a drug product, especially when applied across multiple unit operations or to streamline drug product manufacture.