Andreas Stromberger and Christian Herz are both chemical laboratory technicians and are working as process chemists in the pharmaceutical API division at Excella GmbH & Co.KG, Feucht, Germany. Since their apprenticeships to become chemical laboratory technicians, both have collected extensive practical work experience (Andreas 13 years, Christian 16 years) in the area sof API development and process optimization. Their work holistically focusses on the development, scale-up and optimization of API processes from chemical reaction to downstream product isolation, in the lab as well as in commercial operations.
Investigating a Complex Polymorph and Pseudo-Polymorph Landscape
Developing crystallization processes with target particle quality attributes is a key objective in the pharmaceutical industry. This study investigates the applicability of in-situ Raman in order to understand formation pathways of desired and undesired polymorphs as well as possible intermediate pseudo-polymorphs. This presentation discusses how to overcome common crystallization process development challenges like:
- Uncertainty when to take samples
- Concerns around non-robust sampling
- Possible polymorph transformations before offline analysis can be performed
In-situ Raman successfully tracks the form information of the particle population continuously and in real time, providing comprehensive form information without the need for sampling and offline analysis. The results conclusively show the appearance of mixed polymorphic forms and polymorph transformation via an intermediate solvate form, which leads to the conclusion that in-situ Raman is an asset for optimal crystallization process development.
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