Crystallization &
Particle Engineering

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Crystallization Process Development

WuXi STA’s crystallization team is experienced in crystallization process development and milling & micronization process development. Our expertise includes but not limited to polymorph, purity, residual solvents, particle size distribution, morphology, filtration, and drying investigation to ensure delivery of drug substance with desired qualities. The R&D labs are located at Shanghai Waigaoqiao, Shanghai Jinshan and Jiangsu Changzhou sites.

Crystallization team is equipped with powder X-Ray Diffractometers (pXRD), Differential Scanning Calorimeters (DSC), Thermal Gravimetric Analyzers (TGA), Polarized Light Microscopes (PLM), Scanning Electron Microscopes (SEM), Particle Size Distribution analyzers (PSD), and Dynamic Vapor Sorption (DVS) for solid state analysis. Process Analytical Technology (PAT), such as Focused Beam Reflectance Measurement (FBRM), Online IR (React IR), and BlazeMetrics, are also used for the development.

In 2023, crystallization team supported process R&D for 500+ compounds, including crystallization process development for 70+ late-phase and commercial steps. Learn more about our salt and polymorph screening services

Milling and Micronization

We routinely provide four types of micronization support from laboratory scale to production scale. And we also support high potency compounds with an Occupational Exposure Limit (OEL) of 10 ng/m³.