Early in the development of recombinant MAbs, a large number of harvest cell culture (HCC) samples must be screened for IgG titer. Affinity chromatography employing a Protein A ligand is often used to determine the MAb concentration as well as to purify it for downstream aggregate and charge variant analysis. The challenge facing the analytical laboratories in the pharmaceutical industry is to develop a high - throughput and robust titer assay.
United States
