In light of the balancing act among quality, speed, and cost, collaborative partnering between pharmaceutical companies and contract research/manufacturing organizations is becoming increasingly important in meeting our goals of delivering high quality APIs and drug products to patients. This talk will summarize the challenges the pharmaceutical industry is facing today and will continue to face in the future in the area of API crystallization engineering and manufacturing.

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Problems associated with polymorphic instability and increasingly insoluble drug candidates represent white space to innovate novel forms and processing methods with better properties in the drug product. But the journey from identifying new solid forms to creating engineered particles with optimal formulation properties has often been too inefficient to realize this goal.

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Diverse crystallization challenges encountered by CfPC (Center for Pharma Crystallization) and our clients will be analyzed systematically to provide insights into main bottleneck problems in today’s drug development programs.

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