(344a) API Particle Formation: Technological Approaches to Forming Unique API Characteristics

The formation of highly differentiated APIs to enable specific downstream filtration, drying and drug product performance, in terms of flowability, blending, content uniformity and in vitro disintegration and dissolution is becoming an ever important feature in pharmaceutical process design.

Within this presentation the application of technological platforms, such as continuous processing, hybrid batch/continuous wet milling enabled system, will be discussed in detail. A series of case studies will show the work flow and design details associated to engineering and population balance models, reactor design, supersaturation monitoring / control to enable the delivery of highly differentiated API particle characteristics. The interface between the drug substance and drug product will be discussed at length to demonstrate the ability of engineering strategies to enable predictable downstream process performance.