(260g) Commercial Control Strategy Development for a High Shear Wet Granulation Process

During development of an oral drug product commercial-scale manufacturing process using high shear wet granulation, challenges were encountered due to a change in the drug substance manufacturing process and resulting API properties. These challenges required a redesign of the manufacturing process and implementation of a control strategy to ensure/demonstrate equivalency of the granules, that when processed downstream, achieved the desired drug product critical quality attributes. Appropriate PAT tools were used to facilitate development at the commercial scale. The final control strategy uses real-time data monitoring, complex recipe control and formal in-process control (IPC) requirements.

All authors are employees of AbbVie and may own AbbVie stock. AbbVie sponsored and funded the study; contributed to the design; participated in the collection, analysis, and interpretation of data, and in writing, reviewing, and approval of the final publication.