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 analysis as well as protein characterization techniques that alone or in combination provides 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.

主权项

1. A method for monitoring a polyclonal cell culture that produces a recombinant polyclonal antibody, wherein the polyclonal cell culture comprises individual clones each of which expresses a distinct member of the recombinant polyclonal antibody, said method comprising:
obtaining a supernatant sample from said cell culture, analyzing aliquots of said sample by at least one protein characterization technique selected from chromatographic analyses which separate proteins according to a physicochemical property other than size, such that the proportion of each distinct antibody member relative to the other distinct antibody members within said sample is determined.