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AssigneeAsahi Kasei Kabushiki Kaisha
InventorsFumihiko Yamaguchi, Hitoshi Mizomoto, Shinya Hamasaki, Takena Mochizuki
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A method of accurately separating immunoglobulin monomers by subjecting an immunoglobulin solution containing at least immunoglobulin monomers and immunoglobulin aggregates to cross-flow filtration using an ultrafiltration membrane, an ultrafiltration membrane module, and a cross-flow filtration apparatus. The method can separate immunoglobulin monomers by subjecting an immunoglobulin solution containing at least immunoglobulin monomers and immunoglobulin aggregates and having an immunoglobulin concentration of 1 to 150 g/L to cross-flow filtration using an ultrafiltration membrane having a molecular weight cut-off of 100,000 or more and less than 500,000 so that immunoglobulin monomers passes through the ultrafiltration membrane with a permeability of 80% or more while achieving a fractionation performance in which the permeability ratio of immunoglobulin dimers to immunoglobulin monomers that pass through the ultrafiltration membrane is 0.20 or less.
A method of separating an immunoglobulin monomer comprising filtering an immunoglobulin solution containing at least an immunoglobulin monomer and an immunoglobulin aggregate and having an immunoglobulin concentration of 1 to 150 g/L with cross-flow filtration using an ultrafiltration membrane having a molecular weight cut-off of 100,000 or more and less than 500,000, forming a cake layer on the surface of the ultrafiltration membrane, maintaining the immunoglobulin concentration in an immunoglobulin stock solution during filtration within the range of 50 to 200 when the immunoglobulin concentration before filtration is referred to as 100, and passing the immunoglobulin monomers through the cake layer to obtain an immunoglobulin permeation solution.
A method of separating an immunoglobulin monomer from an immunoglobulin aggregate comprising filtering an immunoglobulin solution having an immunoglobulin concentration of 1 to 150 g/L with cross-flow filtration using an ultrafiltration membrane having a molecular weight cut-off of 100,000 or more and less than 500,000, forming a cake layer on the surface of the ultrafiltration membrane, maintaining the immunoglobulin concentration during filtration within the range of 50 to 200 when the immunoglobulin concentration of an immunoglobulin stock solution before filtration is referred to as 100, and passing the immunoglobulin monomers through the cake layer to obtain an immunoglobulin permeation solution.
Dependencies are inferred from the claim text.