(671a) Suitable Raw Material Attributes for Continuous Manufacturing of a Drug Product Via Direct Compression

Continuous manufacturing for small molecule drug products is a rapidly maturing technology for innovator pharmaceutical companies and contract manufacturing organizations, supported by intensive study at academic research institutions. Of particular interest are the raw material properties which predict behavior in the novel unit operations of feeding and continuous blending, as well as their impact on residence time distributions. This study presents a thoughtful approach to the selection and justification of raw material property measurements based on process and product risks, predictive power, laboratory resource utilization, accuracy, robustness, and long-term sustainability. A suitable risk-based raw material monitoring plan for a continuous direct compression product is proposed and discussed.