Process Development
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BioDuro-Sundia's process development services support drug substance production, providing an efficient path to manufacture API or intermediates. Our extensive services support production of API for GLP toxicology studies, IND-enabling studies, clinical studies, and commercialization efforts. Services Areas: Route Design & EvaluationDesign & evaluate potential synthetic routesMaterial & production cost analysis of each routeProcess OptimizationCondition screeningsModification work-up & isolation processShort-path distillation, column purificationProcess CharacterizationImpurity profile controls (purge/fate)Characterize of Critical parameters (IND enabling)Safety assessment, PGI impurity controlsScale-Up Demonstration Demonstrate the process on kilo scaleReaction Engineering Isolation and crystallization studies such as solvent screening and selection and solubility studyImpurity profile controlling such as impurity structure elucidation and impurity purge/fateEnabling Technologies Flow Chemistry Special knowledgeDiverse reaction typesCarbohydrate Chemistry Complex structure & sensitive moleculesMono-saccharide synthesis experienceIsolation & purification techniquesPeptide Chemistry Unnatural amino acids synthesisAssembling strategy for cost & quality controlsKilo scale synthesis up to 5-6 amino acid
