(95c) Applied Crystallization in Pharmaceutical Industry: Old Lessons and New Tools in Bridging the Drug Substance / Drug Product Synergy Gap (invited)

Crystallization from solution is a typical last synthetic step utilized in the pharmaceutical industry for the production of the active pharmaceutical ingredient (API). Following the solid/liquid separation step (filtration and drying), the API is utilized by the Formulation/Pharmaceutics groups for development of various drug product prototypes such as tablets and capsules. Time to market and critical supply needs for pre-clinical and clinical material forces the process development teams for drug substance and drug product to operate in parallel and almost totally independent paths. Some case studies will be presented describing unique crystallization development and scale-up challenges and some innovative solutions using old lessons from the published literature. In addition, new developmental tools for studying crystallization and post-processing operations will be illustrated in order to demonstrate use of more efficient and product focused experimentation during the supply and early development phases.