This presentation focuses on the creation and implementation of an integrated framework to streamline CDC in therapeutic projects. This framework combines in-silico tools and miniaturized manufacturing and characterization platforms to support Particle Engineering and formulation selection.
The CrystalGrower software is used early in this framework to identify the most promising levers for bottom-up Particle Engineering strategies. Small batches of API with a range of particle properties (size and morphology) are prepared using both bottom-up and top-down approaches. The characterization of the particle and powder properties of these batches allows for the construction and subsequent interrogation of an appropriate database.
The database is then combined with EleGent’s proprietary database and optimization software. This allows for the determination of the most suitable combination of excipients for direct compression settings for a wide range of constraints (drug loading, particle size and shape, etc.). The most suitable combinations of API and excipients are then tested on the tablet press.
This framework was successfully demonstrated in the context of UCB’s therapeutic projects. The results highlight the acceleration in formulation and process development that can be achieved thanks to the integration of the different modules of the workflow. The use of in-silico tools for the selection of the most appropriate Particle Engineering strategy and the science-based selection of the most appropriate formulation create unparalleled flexibility and allow for better and more sustainable interfacing between drug substance and drug product.