Development and Validation of a Corona CAD Method for Simultaneous Determination of Peptides, Lipids and Lipid-Impurities in the Synthetic Pulmonary Surfactant Formulation Surfaxin


Rigorous validation of an analytical method utilizing the Corona CAD for measuring major components and impurities in a peptide/lipid drug product formulation is presented in this white paper by ESA Biosciences, Inc. The Corona CAD met or exceeded specification requirements (precision, ruggedness, LOQ, etc.). Implementation resulted in significant time and cost savings for the researchers as sample preparation was greatly simplified and a number of analyses were able to be performed simultaneously.