STERILE CHROMATOGRAPHIC RESIN AND ITS APPLICATION IN PRODUCTION METHODS Russian patent published in 2023 - IPC B01D15/10 B01D15/20 C07K1/16 C07K1/18 C07K1/22 B01J20/00 A61L2/08 

FIELD: chromatography.

SUBSTANCE: method for reducing bioburden in a chromatography resin, comprising exposing a container with a composition of (i) a chromatography resin and (ii) a liquid containing benzyl alcohol and at least two antioxidants to a dose of gamma radiation sufficient to reducing bioburden in the container and chromatography resin, wherein at least two antioxidants are selected from the group consisting of: mannitol, sodium ascorbate, histidine and methionine; and benzyl alcohol and at least two antioxidants are present in amounts sufficient to reduce the loss of binding capacity of the chromatography resin after exposure to a dose of gamma radiation. A composition for a container exposed to a dose of gamma irradiation, containing (i) a chromatography resin and (ii) a liquid containing benzyl alcohol and at least two antioxidants, where at least two antioxidants are selected from the group consisting of: mannitol, sodium ascorbate, histidine and methionine, and benzyl alcohol and at least two antioxidants are present in amounts sufficient to reduce the loss of binding capacity of the chromatography resin when treated with a dose of gamma radiation sufficient to reduce the bioburden in the composition.

EFFECT: preventing a decrease in the binding capacity of the chromatography resin after exposure to a dose of gamma irradiation.

29 cl, 2 dwg, 2 tbl, 2 ex