A Holistic Quality Control Strategy for Peptide Active Pharmaceutical Ingredients (APIs)
The goal of consistently achieving critical quality attributes (CQAs) for synthetic peptide active pharmaceutical ingredients (APIs) may be challenging owing to the complexity of the manufacturing process and the large number of potential sources of variability. […]
The goal of consistently achieving critical quality attributes (CQAs) for synthetic peptide active pharmaceutical ingredients (APIs) may be challenging owing to the complexity of the manufacturing process and the large number of potential sources of variability. This chapter outlines the principles of process design and the development of a comprehensive control strategy for manufacturing peptide APIs of consistent quality. A approach is described that involves process design utilizing a practical application of quality target product profile (QTPP), quality-by-design (QbD), identification and mitigation of risks and process characterization.
A. Swietlow and A. Lower, ed. Royal Society of Chemistry, London, UK, 2019, 194
doi:10.1039/9781788016445-00194