Particle Morphology Hints Impurity Rejection During API Crystallization



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One important aspect of a robust API crystallization process is rejecting reaction impurities of varying concentrations. This is a critical step during the early stages of process development before the first GMP batch and just before the final solvent systems will be selected. However, representative crude API material is often just barely available at that step. Parallel small-scale crystallization platforms are particularly useful and attractive at this stage.

The webinar presents the case study of an API having distinct different morphologies when crystallized from different solvent systems. The presenter showed how this could be used as an advantage during impurity rejection stage. Following the selection of the optimum solvent system, suggestions were also given on how to optimize the seed load and processing conditions for obtaining the desired PSD and solid form across different scales.

 

 

 

 

This webinar was presented by Dr Jochen Schöll, currently working as crystallization process development scientist at MSD Werthenstein BioPharma in Switzerland. After obtaining his PhD at ETH Zurich in 2006 on the characterization of nucleation and growth kinetics using PAT, he joined Mettler Toledo AutoChem as Technology and Application Consultant for Particle Systems until 2011. 

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