Peptide-based APIs are getting more complex and the bar for their downstream purification is raised constantly. Screening for the optimal silica-based stationary phase in Reversed Phase High Pressure Liquid Chromatography (RP HPLC) is often time-consuming and a financial burden in peptide manufacturing. Usually the last step, polishing for purification >95%, has strong impact on process economy, especially in the scale-up of RP HPLC processes.
This presentation aims to:
- Describe the important physicochemical parameters of silica particles and bonded media;
- Highlight pore and particle size, and carbon density to point out key roles they play in the purification process;
- Outline in-house pharma communication to develop efficient RP HPLC processes for lead compounds to manufacturing.