The purification process of crude synthetic peptides as well as recombinant Insulin typically includes a reversed phase high performance liquid chromatography (HPLC) step. A single step process is most desired but a multiple step process is often necessary to achieve purity greater than 98% especially with long peptide and recombinant proteins like human Insulin. When a multistep process is used, the first steps are designed to remove most of the undesired components whereas the last step is developed to further “polish” the API to the desired purity level.
This presentation will cover the current state of the art for large scale preparative HPLC purification of synthetic peptide. The chemical and physical property of the purification packing material will be discussed as well as the mobile phase and critical process parameter needed to develop robust and scalable process. A revolutionary hybrid silica based stationary phase designed for the purification of peptide/proteins prone to aggregation will be highlighted and several purification case studies such as GLP-1 analogues and Insulin analogues will be presented.