| abstract |
In a method for separating an immunoglobulin monomer with high accuracy by cross-flow filtering an immunoglobulin solution containing at least an immunoglobulin monomer and an aggregate thereof using an ultrafiltration membrane, a permeate To provide a separation method capable of reducing the amount, an ultrafiltration membrane module thereof, and a crossflow filtration device. An immunoglobulin solution containing at least an immunoglobulin monomer and an aggregate thereof using an ultrafiltration membrane having a fractional molecular weight of 100,000 or more and less than 500,000, and having an immunoglobulin concentration of 1 to 100 g. In crossflow filtration of a solution that is / L, perform crossflow filtration without adding a diluent to the immunoglobulin solution at least halfway through the filtration step, or (a) without adding a diluent to the immunoglobulin solution After the step of performing the cross flow filtration, the amount of the permeate is reduced by performing the step of performing the cross flow filtration while adding the diluent (b), and the transmittance of the immunoglobulin monomer is 80%. As described above, an immunoglobulin monomer can be separated with a fractionation performance such that the permeability ratio between the immunoglobulin monomer passing through the ultrafiltration membrane and the dimer is 0.20 or less. [Selection figure] None |