abstract |
: nProvided herein are methods of reducing bioburden of (e.g., sterilizing) a nchromatography resin that include exposing a container including a composition nincluding a chromatography resin and at least one antioxidant agent and/or chelator to a ndose of gamma-irradiation sufficient to reduce the bioburden of the container and the nchromatography resin, where the at least one antioxidant agent and/or chelator are npresent in an amount sufficient to ameliorate the loss of binding capacity of the nchromatography resin after/upon exposure to the dose of gamma-irradiation. Also nprovided are reduced bioburden chromatography columns including the reduced nbioburden chromatography resin, compositions including a chromatography resin and at nleast one chelator and/or antioxidant agent, methods of performing reduced bioburden ncolumn chromatography using one of these reduced bioburden chromatography ncolumns, and integrated, closed, and continuous processes for reduced bioburden nmanufacturing of a purified recombinant protein. nFIG 14n9/11 n80 n4 0 ... .....E. .. .. ... .. .... . ... .. .... . nOAA n......... nFIG 14 |