A METHOD FOR CHARACTERIZATION OF A RECOMBINANT POLYCLONAL PROTEIN

摘要

The present invention provides a characterization platform that can be used to assess the amount of different antibodies produced by a polyclonal cell line during production, as well as batch-to-batch consistency of the antibodies present in the polyclonal products. The structural characterization platform is based on removal of the heavy chains and separation of the light chains remaining via a chromatographic separation technique followed by mass spectrometry analysis on the intact light chain species.