METHOD FOR CHARACTERISING RECOMBINANT POLYCLONAL PROTEIN Russian patent published in 2013 - IPC G01N33/53 G01N33/68 C07K16/00 C12P21/08

Abstract RU 2476886 C2

FIELD: medicine.

SUBSTANCE: invention presents a method for characterising a light chain type in a composition of recombinant polyclonal antibodies which may be used for assessment of various antibodies produced by a polyclonal cell line in the process of production, as well as batch consistency of the antibodies found in the polyclonal products. A method for structural characterisation is based on heavy chain removal and residual light chain separation by chromatographic separation and mass spectrometry of intact light chain types. What is also disclosed is a method for detecting the presence of versions in intact light chain populations in two or more compositions of the recombinant polyclonal antibodies prepared of one polyclonal cell culture in different moments of time in the process of cultivation, or of various polyclonal cell cultures in a specific moment of time.

EFFECT: use of the invention enables making the specific drug batch complying with the pre-set production specification.

19 cl, 8 dwg, 2 tbl, 2 ex

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RU 2 476 886 C2

Authors

Rasmussen Lone Ker

Fransen Torben P.

Ehngstrem Anders

Khol'Mberg Ehrland

Persson Pia

Dates

2013-02-27—Published

2008-11-20—Filed