Accelerating speed to market through solid state & crystallization development: Polymorph case study

Case study

Our on-demand webinar, "Accelerating speed to market through solid state & crystallization development”, dives into a polymorph case study in which a more stable polymorph unexpectedly emerged during lab development in preparation for a manufacturing campaign.

For this particular API, a polymorph screen had been carried out and didn’t detect the more stable polymorph. Unfortunately, the solubility of this polymorph was 10x lower than the target polymorph. As a result, there was a loss of process efficiency — considerably more batches were required, which translated to slower turnaround and yield loss. Alternatively, other options included: 1) run with the existing process and keep fingers crossed, 2) change the plant design, and 3) change the process.

Watch the webinar clip to explore the pros and cons of every option, learn which option eventually won, and explore the importance of having a backup plan in place. Ultimately, there’s no way of accurately predicting the most stable polymorph; you can merely mitigate risk and plan accordingly.