Control Strategies for Synthetic Therapeutic Peptide APIs Part III: Manufacturing Process Considerations

The United States Pharmacopeia (USP) Therapeutic Peptides Expert Panel was formed in 2013 at the direction of the Monographs-Biologics & Biotechnology Expert Committee to evaluate quality attributes for synthetic peptides based on currently available regulatory guidance and expectations. This series of three articles by the panel explores the current manufacturing and regulatory landscape and provides a comprehensive overview of quality attributes to be considered for successful synthetic peptide API from development through manufacturing to lot release. The first article (1) covered analytical characterization methods, lot-release tests and points to consider for synthetic peptide API manufacturers entering the market. The second article (2) focused on raw materials used in the chemical synthesis of peptides. This last article in the series is devoted to manufacturing processes and impurity control for synthetic peptide APIs.