Bioanalytics – Chemical
2019 PharmSci 360
Liquid chromatography and tandem mass spectrometry (LC-MS/MS) is increasingly being used as an alternative platform to ligand binding assays (LBA) as an accurate and reliable technique to measure therapeutic antibodies in biofluids. MS-based quantitation of the therapeutic antibodies is generally performed using the surrogate peptide approach, however intact mass analysis is also of interest within the industry. Surrogate peptide approach is known to offer good sensitivity and is amenable to conventional MRM quantitation whereas the intact mass analysis enables the quantitation of protein at an intact level which provides structural information that LBA infers from using specific capture and detection reagents. Within the intact mass analysis approach, variants of data processing also play a key role in the assay performance. The talk will be focused on the comparative case study to assess quantitative results generated using the surrogate peptide and the intact mass analysis approach on the representative biologic (Pembrolizumab).