A PROCEDURE FOR STRUCTURAL CHARACTERIZATION OF A RECOMBINANT POLYCLONAL PROTEIN OR A POLYCLONAL CELL LINE

摘要

The present invention provides a structural characterization platform that can be used to assess the stability of a polyclonal cell line during production, as well as batch-to-batch consistency of the final polyclonal products. The structural characterization platform is based on genetic analyses as well as protein characterization techniques that alone or in combination provide the necessary information to characterize the polyclonal cell line and final products. The collection of different homologous proteins to be analyzed with the platform techniques is for example a recombinant polyclonal antibody or a mixture of monoclonal antibodies.