(656e) Robust Process Design for a Terminal Wet Milling Process

Over the last few decades, late-stage drug substance process development has moved away from a paradigm that requires extensive testing of active ingredients to an enhanced approach that focuses on process understanding and risk management and ensures robust process performance and additional manufacturing flexibility.

For terminal wet milling processes designed for form and particle size control, consistency across scales, while maintaining high drug substance quality, is essential. This talk will cover experimentation and process analysis to identify critical and non-critical process parameters, sources of process variability, scale dependencies, and experimental and modeling strategies to support the commercialization of a terminal wet milling process.