FIELD: medical resins.
SUBSTANCE: methods for reducing the bioburden (for example, sterilization) of a chromatography resin. A composition is proposed for reducing the bioburden of an affinity chromatography resin containing a protein ligand after exposure to a dose of gamma radiation, containing (i) an affinity chromatography resin containing a protein ligand, and (ii) a liquid containing from about 15 mM to about 35 mM sodium ascorbate, from about 15 mM to about 35 mM methionine, from about 15 mM to about 35 mM mannitol, and from about 15 mM to about 35 mM histidine. Also a container for reducing the bioburden of an affinity chromatography resin containing a protein ligand after exposure to a dose of gamma radiation containing the specified composition is proposed.
EFFECT: reducing the bioburden of an affinity chromatography resin.
8 cl, 17 dwg, 4 tbl, 5 ex
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