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Crystallization and Particle Engineering
The step where drug substance and drug product meet.
What crystallization decides
Applied across 100% of API steps. Crystallization determines polymorph, purity, and particle size, which in turn determine how the drug substance behaves in formulation.
The crystallization team develops both the crystallization process and the milling and micronization process. Its scope covers polymorph, purity, residual solvents, particle size distribution, morphology, filtration and drying, to deliver drug substance with the qualities the formulation needs.
R&D laboratories are at the Shanghai Waigaoqiao, Shanghai Jinshan and Changzhou sites.
Solid-state analysis
The team is equipped for the full solid-state characterization set:
- Powder X-ray diffraction (pXRD)
- Differential scanning calorimetry (DSC)
- Thermal gravimetric analysis (TGA)
- Polarized light microscopy (PLM)
- Scanning electron microscopy (SEM)
- Particle size distribution analysis (PSD)
- Dynamic vapor sorption (DVS)
Process analytical technology
Development is run with process analytical technology in line: focused beam reflectance measurement (FBRM), online infrared (React IR), and BlazeMetrics.
Milling and micronization
Four types of micronization support are provided routinely, from laboratory scale to production scale.
- Wet mill — IKA Process Pilot 2000/4, 2000/10 (stainless steel and Hastelloy) and 2000/20 (stainless steel)
- Pin mill — pilot scale and commercial scale
- Jet mill — laboratory, pilot and commercial scale
- Cone mill — pilot scale and commercial scale
High potency compounds are supported at an occupational exposure limit of 10 ng/m³.