Problem Solving
Scientific Expertise
Innovative Approach
Need
The client had attempted to conduct a peptide bioequivalence study for using standard Enzyme-linked immunosorbent assay (ELISA) methods
The client and bioanalytical laboratory had determined that the ELISA methods did not have the dynamic range to the range of concentrations expected following dosing of a peptide drug; this had led to multiple dilutions and emerging stability issues for the samples
Approach
Development and validation of an LC-MS/MS method for the peptide solved the dynamic range, dilution and stability issues, particularly after a protease inhibitor cocktail was customized to enhance analyte stability
Benefits
Although the method remained challenging to perform, the client was able to support their bioequivalence studies and make an application
