Challenges in Process Development
Drug product development includes a complex and wide range of processes, from the drug substance, processing of intermediates, and the manufacturing of the final drug product. These steps must be optimized to ensure both consistent quality and methodologies that can be brought to scale.
In the development of solid dosage forms, controlled release products, and a variety of drug platforms, the microstructural properties of components can evolve throughout processing and manufacturing. Specifically, the size and distribution of the active pharmaceutical ingredient (API), excipients, and porosity are critical to be controlled and monitored throughout downstream and upstream processes. Most importantly, characterizing these microstructure features can provide crucial guidance on selecting the optimal process and manufacturing conditions.
Due to the small scale of these microstructures, a high-resolution technique is required to analyze their properties. Further, sample representativeness must be ensured. Current analytical methodologies are lacking in at least one of these areas, and the insights into process development are accordingly restricted.
In the case of tablet manufacturing, a wide range of processes and intermediates can be involved. Its critical to optimize and understand microstructure evolution throughout upstream and downstream processes.
The DigiM Solution – Advancing Process and Manufacturing Decisions
At DigiM, we apply high-resolution imaging and AI analytics to quantitatively evaluate the impact of process and parameter on drug microstructures. With non-destructive 3D X-ray microscopy, the morphology and characteristics of thousands of spray-dried particles can be evaluated in one experiment. The relationship of intermediates, tableting performance and compaction, and dissolution can be fully understood. For lyophilization products, our techniques can help evaluate quality parameters associated with sublimation process, and ensure that the drug is properly preserved and protected. In controlled and modified release areas, our analysis can help determine the release mechanism and predict release profile.
Our analytics have been applied throughout the development cycle, helping optimize and link downstream and upstream processes.
Application of XRM imaging to visualize spray-dried particle morphology, for batches manufactured under different outlet temperatures.