Tipo de estudio: Desarrollo de procesos de cristalización que abarca cribado de polimorfismo, estudios de solubilidad y caracterización de diagramas de fase
Cumplimiento regulatorio: Estudios realizados conforme a procedimientos de laboratorio alineados con las BPL para respaldar la documentación regulatoria
Experiencia en área terapéutica: Ampliamente aplicable a programas de IFA de molécula pequeña en distintas áreas terapéuticas, incluidos proyectos de separación de enantiómeros

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This service builds the technical knowledge base needed for crystallization process development, covering polymorphism, solubility and phase-diagram studies. Applications span product recovery, yield and purity optimization, polymorphism control, enantiomer separation, converting oils into crystalline powders, particle engineering, filtration performance (cake resistance and compressibility) and drying to target residual solvent levels. Processes are designed with scale-up in mind, avoiding fast cooling and using industrially viable solvents, and matched to the client's plant capabilities such as cooling and filtration systems. Critical process parameters are identified and studied to establish robust operating conditions, with PhD-level crystallization specialists handling development from scratch as well as optimization and troubleshooting of existing processes.