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.