Using QbD and DOE to Identify Critical Process Parameters As They Relate to Operating Ranges at Manufacturing Scale

The use of Quality by Design (QbD) and Design of Experiments (DOE) during process development is key to transparent risk management and maintaining safety, efficacy, and efficiency. An important step is identifying critical process parameters (CPPs) to ensure that a product meets defined quality goals. Regeneron will define strategies for identifying CPPs that emphasizes the relationship between studied ranges and manufacturing operating ranges.