Process Development

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 & Evaluation

• Design & evaluate potential synthetic routes
• Material & production cost analysis of each route

• Condition screenings
• Modification work-up & isolation process
• Short-path distillation, column purification

• Impurity profile controls (purge/fate)
• Characterize of Critical parameters (IND enabling)
• Safety assessment, PGI impurity controls

• Demonstrate the process on kilo scale

• Isolation and crystallization studies such as solvent screening and selection and solubility study
• Impurity profile controlling such as impurity structure elucidation and impurity purge/fate

• Special knowledge
• Diverse reaction types

• Complex structure & sensitive molecules
• Mono-saccharide synthesis experience
• Isolation & purification techniques

• Unnatural amino acids synthesis
• Assembling strategy for cost & quality controls
• Kilo scale synthesis up to 5-6 amino acid