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Prep-HPLC, SFC, and SMB
For molecules where crystallization will not deliver the purity or the separation.
Chromatographic purification at manufacturing scale
98 compounds manufactured. Chromatographic purification at manufacturing scale, for molecules where crystallization will not deliver the purity or the separation. Supercritical fluid chromatography and simulated moving bed both run alongside conventional preparative HPLC.
The platform purifies APIs, high potency APIs, chiral compounds, and intermediates. The teams handle method scale-up, method optimization, process validation, and pilot and commercial manufacturing, so a separation developed for a clinical batch is the one that runs at launch.
Facilities at Changzhou, Shanghai Jinshan, and Taixing provide purification capacity from gram scale to metric-ton scale.
Equipment
- Prep-HPLC — 15 sets with dynamic axial compression (DAC) columns from 8 cm to 80 cm, handling all classes of synthetic molecule including highly potent compounds
- SFC — 3 sets with columns from 10 cm to 15 cm
- SMB — 1 set with columns from 5 cm to 8 cm
Inside containment
Preparative chromatography is available for high potency compounds at an occupational exposure limit of 10 ng/m³, with prep-HPLC installed in the high potency plants.