A method for characterization of a recombinant polyclonal...

G - Physics – 01 – N

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G01N 33/68 (2006.01) C07K 16/00 (2006.01)

Patent

CA 2702322

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.

La présente invention porte sur une plateforme de caractérisation qui peut être utilisée pour évaluer la quantité de différents anticorps produits par une lignée cellulaire polyclonale pendant la production, ainsi qu'une cohérence de lot en lot des anticorps présents dans les produits polyclonaux. La plateforme de caractérisation structurale est basée sur le retrait des chaînes lourdes et la séparation des chaînes légères restantes par l'intermédiaire d'une technique de séparation chromatographique, puis d'une analyse par spectrométrie de masse sur l'espèce de chaîne légère intacte.

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