Simplifying cGMP Crystallization
Can you simplify my cGMP crystallization?\
How we said yes:
The crystallization conditions were effective at cleaning up the intermediate to an acceptable purity level. However, the crystallization system was tricky as it consisted of two solvents and the ratio of each relative to product was critical.
- Required laboratory use testing when running this step in plant.
Quantum mechanics calculations were performed on the structure of the intermediate to determine optimal solvents.
- Based on the electron density of the intermediate structure, solubility coefficients for various solvents were determined.
- This identified two solvents that afforded high recovery and desirable cleanup when impurities were present in the intermediate.
- The higher boiling point solvent was the favored azeotrope chosen for its reaction with the solvent mixture.
- At the conclusion of the reaction, a solvent exchange was implemented; the batch was then cooled to effect crystallization.
- All known process impurities were purged to acceptable levels.
- Yields matched that of the original process.
The yes formula benefits:
All quality expectations were met or exceeded.
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