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By harnessing solid-state characterization and crystallization development from early stages, pharmaceutical companies can accelerate their product timelines and minimize costly errors. Understanding the solid form landscape is crucial for creating a scalable crystallization process that ensures purity and optimizes bioavailability. This proactive approach in defining solid-state parameters early in development enhances control over drug substance and drug product processes, leading to more effective development.
This article highlights the importance of a global network and integration with drug product formulation development to speed up market readiness. Early investment in synthetic route finding and a better understanding of the solid-state properties and crystallization of the drug candidate can avoid the trial-and-error cycle and streamline the progression to commercialization. By focusing on these advanced methodologies, pharmaceutical companies can refine their production strategies and improve outcomes.