API Particle Development Information

Problems with API solid state are often overlooked in drug development. Selecting a sub-optimal version, lack of polymorph control, and poor design of the API step can halt a clinical program or delay commercialisation. My SME expertise covers: Risk based development, version screening, polymorphism, hydration and solvation, API crystallisation development, downstream processing, filtration, washing and drying, particle size reduction, crystallization scale-up, quality by design, technical transfer, physical properties data interpretation.