Developing A Robust Crystallization Process For A High-Molecular-Weight Peptide

Developing a scalable crystallization process for peptides can be challenging, especially when multiple solid forms, polymorphic impurities, and solvent limitations impact product quality and manufacturability.

In this case study, a pharmaceutical company partnered with Solvias to develop a robust crystallization process for a high-molecular-weight peptide. By combining advanced solid-state expertise with in situ process monitoring and systematic process optimization, the team established a reproducible, manufacturing-ready process that consistently produced the desired polymorph while transitioning to lower-molecular-weight solvents.

The optimized process improved robustness, mitigated phase separation and gel formation, and supported successful technology transfer.