Downstream Processes for peptide manufacturing: Optimization strategy and latest technical trends
Expert views
This article highlights the key steps in the development and implementation of a proper purification strategy for the manufacture of peptide APIs. Our ambition is to recommend a structured methodology, including a good understanding of the separation mechanism to develop the process and to apply the latest technologies for the optimization of the purification step to reach the best performance of the manufacturing process. […]
Purification is a critical unit operation in the manufacturing route of a peptide. Its optimization requires the expertise of the chromatographer together with the skills of process engineers to select the most suitable solution to produce peptide APIs. The selection of the chromatographic conditions is of paramount importance, and an appropriate expertise and methodology are crucial to propose the appropriate process development strategy throughout the clinical trials. Mastering the latest technologies also offers great opportunities for the implementation of an efficient and
reliable process.
reliable process.
2/2021 – April, OLIVIER LUDEMANN-HOMBOURGER1, PER MÖLLER, FRANCOIS KUSTER