| 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 adsorbed 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±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 steps of the method; and (III) carrying out the virus inactivation (step iii') by using chemicals at a temperature of 30° C.±2° C. for at least 4 hours. Anticomplementary activity is typically below 1 CH50/mg immunoglobulin.
|
