This episode explains the core principles of Quality by Design (QbD) in pharmaceutical manufacturing, emphasizing its role in creating robust and reproducible processes. The conversation centers on identifying critical process parameters (CPPs) – those key variables that directly impact the critical quality attributes (CQAs) of the final drug product. We'll explore how manufacturers use techniques like design of experiments (DOE) to systematically understand the relationship between CPPs and CQAs.

The dialogue will delve into risk-based design, demonstrating how it moves from a theoretical concept to a practical tool. We'll show how manufacturers proactively identify potential sources of variability and develop control strategies to mitigate risks. Real-world case studies from OPR&D are utilized, highlighting how unexpected challenges, such as gelling issues or unwanted side reactions, are addressed through a QbD approach. Examples include, scaling up a reaction, a 100 liter reactor, methyl ester hydrolysis step, continuous flow conditions.