Protein Aggregate Assessment of Ligand Binding Assay (LBA) Reagents Using SEC-MALS

Ligand Binding Assays (LBAs) used for large molecule drug development can necessitate conjugation of a drug to one or more different tags. To help ensure that LBAs utilizing conjugated drug reagents perform consistently over time and provide high quality data, each lot of conjugated material should be characterized functionally and biophysically prior to being incorporated into the LBA. One potential source of lot-to-lot variability is aggregation, which may be inherent to the drug, induced by the conjugation process and/or handling of the reagents. SEC-MALS is a superior method for assessing the aggregate profiles of LBA reagents.