Development of Continuous Twin Screw Wet Granulation and Drying

Continuous or advanced manufacturing technologies (AMTs) shorten development time, improve drug product quality, and lower overall costs. This ensures that a robust supply of high-quality drugs is available to a broader patient population. This presentation will discuss the integration of two traditionally separate unit operations – wet granulation and drying – to enable an AMT for twin screw wet granulation. The integration of in-line PAT methods, automated collection of data-rich experimentation, and integrated feedback control systems will enable precise tuning of the size and moisture content of granules. PAT using a high-speed camera and NIR probe are developed for bench-scale twin screw extruder and continuous dryer. The data architecture is designed to accept PAT data as feedback to adjust process parameters. Future work to integrate multiple feeders for a blending step in the continuous manufacturing of wet granulation will highlight the significant potential and commercial impact of early AMT.