Improved peptide analytical technologies and the impact on process development
The regulations controlling the use of synthetic peptides as therapeutics has changed significantly over the last number of years with peptides now being viewed as closer to small molecules in terms of process control, structural characterization and individual impurity limits. In parallel to the increased regulatory requirements, advances in analytical technologies have led to an increased scrutiny of therapeutic peptides, making the understanding and control of individual impurities formed in the peptide manufacture process, critical.
