Crystallization Process Development: Peptide Crystallization

By Hayley Reece, Executive Director, Technical Services, and Laura Allan, PhD, Sr. Scientist, Crystallization, Cambrex

Peptides play an increasingly important role in drug discovery with their potential to offer therapeutic agents beyond traditional hormone replacement therapies. In addition to therapeutic agents, peptides are often subcomponents in other drug substances. Regardless of the application, mastering peptide crystallization opens possibilities for large-scale processing in pharma applications.

The molecular complexity of peptides may have kept them out of development pipelines in the past, but innovations in synthesis and purification have supported their recent momentum as alternatives to small molecules for addressing unmet medical needs. Still, peptides present a particularly challenging class of molecules in crystallization process development. Success of scale-up crystallizations relies on a robust crystallization process to control the thermodynamic and kinetic factors that impact the solid form.

Given the difficulty of peptide crystallization, why do companies invest the time and resources into pursuing a crystalline form of their peptide? Having a crystalline solid form offers clear advantages compared to their amorphous counterparts.