Developing a robust crystallization process to isolate the optimal solid form of an API is an essential step in API development. Identifying the crystallization approach, solvent system(s), controlling form, crystal habit and delivering a consistent uniform PSD from a single process step can be very challenging. Applying expertise in, solid state, PAT and computational modelling all underpin our development of crystallization processes, allowing us to deliver the best outcome at the required scale. We also work on remediating existing crystallizations, which can have a variety of issues such as oiling out, isolating the wrong polymorphic form or just long filtration times. Understanding the crystallization behaviour of a molecule can help: Maximise process yields Improve purity Control form, morphology and particle size distribution Create processes suitable for transfer and scale-up Strengthen IP The key to controlled, growth-dominated crystallization is a thorough understanding...
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