METHODS FOR STERILE CHROMATOGRAPHY AND PRODUCTION Russian patent published in 2022 - IPC C07K1/16 C07K1/22 B01D15/20 A61L2/08 

FIELD: biotechnology.

SUBSTANCE: invention relates to methods for chromatography, using gamma-irradiated chromatographic resin, for purification of recombinant protein. The method includes: (a) obtainment of a chromatographic column containing gamma-irradiated cation-exchanging and/or anion-exchanging chromatographic resin; (b) implementation of the first chromatography cycle through columns, where the first chromatography cycle includes reduction of a binding capacity of gamma-irradiated cation-exchanging and/or anion-exchanging chromatographic resin by subjecting gamma-irradiated cation-exchanging and/or anion-exchanging chromatographic resin to impact of a denaturing buffer containing one or more of urea, guanidine hydrochloride, and Triton™ X-100; and (c) implementation of at least one additional chromatography cycle through the column, where the specified column is subjected to impact of the specified denaturing buffer during each of at least one additional chromatography cycle, and where a flow rate, a volume, and a concentration of the denaturing buffer are selected such that there is essentially a reduction of a binding capacity lost because of gamma-irradiation of cation-exchanging and/or anion-exchanging resin. In addition, the invention relates to integrated, closed, or essentially closed, and continuous methods for the production of recombinant protein.

EFFECT: use of a denaturing buffer allows for reduction of a binding capacity of gamma-irradiated chromatographic resin lost during multiple chromatography cycles.

64 cl, 8 dwg, 2 ex