STERILE CHROMATOGRAPHY AND MANUFACTURING PROCESSES Russian patent published in 2019 - IPC C07K1/16 

FIELD: chemistry.

SUBSTANCE: invention relates to methods for performing chromatography using gamma-irradiated chromatography resin that include: providing a chromatography column comprising a gamma-irradiated chromatography resin; performing the first cycle of chromatography using the column, where the cycle includes the restoration of the binding ability of the gamma-irradiated anion-exchange chromatography resin by exposing the gamma-irradiated anion-exchange chromatography resin to a denaturing buffer; and performing at least one additional cycle of chromatography using the column. In addition, the invention relates to integrated, closed, or essentially closed, and continuous methods for the production of recombinant protein, including the use of at least one chromatography column, including gamma-irradiated chromatography resin, where gamma-irradiated chromatography resin is exposed to the action of a denaturing buffer during each cycle of the method.

EFFECT: use of a denaturing buffer allows to restore the binding ability of gamma-irradiated chromatography resin, lost during many cycles of chromatography.

69 cl, 8 dwg, 2 ex