摘要 |
A method for producing IgG from plasma for medical applications, comprising at least: (i') removal of albumin resulting in an IgG fraction, (ii') purifying IgG from an IgG fraction, which is derived from the IgG fraction obtained in step (i'), by adsorbing IgG to a cation exchanger and collecting the adsorbe d IgG fraction, and (iii') virus inactivation in an IgG fraction derived from the IgG fraction collected in step (ii'). The method is characterized in; (I ) concentrating the IgG fraction obtained in step (i'), (II) adjusting pH to 4.plusmn.0.1 in the IgG fraction released from the cation exchanger in step (ii'), and preferably maintaining the pH below 6.0 during the remaining step s of the method; and (III) carrying out the virus inactivation (step iii') by using chemicals at a temperature of 30 ~C .plusmn. 2 ~C for at least 4 hours . Anticomplementary activity is typically below 1 CH50/mg immunoglobulin.</SDO AB>
|