Bioanalytics – Chemical
2019 PharmSci 360
Here we will present our reasoning and efforts behind establishing an IA-LC-MS based drug assay for Biologics A, a Nanobody®. The workflow consisting of tip-based immune-affinity purification on an Agilent AssayMap followed by in-solution trypsin digestion and MRM monitoring on a TSQ-Vantage triple quad mass spectrometer will be described, and the associated fit for purpose assay qualification for the discovery space will be outlined. As Biologics A moved into development, Discovery BA scientists worked with their counterparts in the regulated space to transfer and modify the assay to meet GLP requirements. As a result, a bead-based immuno-affinity purification workflow on the Hamilton liquid handling platform followed by in-solution trypsin digestion and MRM monitoring on an ABSciex 6500 triple quad mass spectrometer protocol was developed. Methods comparison between the Discovery and Regulated stage assays will be discussed, and validation parameters of the GLP protocol will be highlighted.