Process for preparing immunoglobulin compositions

An IgG-enriched pharmaceutical immunoglobulin composition obtained from pooled blood plasma of at least 500 donors, wherein said composition comprises:

• (i) an IgG content of at least 45 g/l of the composition;
• (ii) an IgG content of at least 95% by weight, based on the total weight of immunoglobulin in the composition;
• (iii) a properdin content of not more than 0.01 μg/mg of total immunoglobulin in the composition;
• and
• (iv) IgG polymers of not more than 0.05% as determined by HPSEC, based on the total amount of IgG in the composition,
• wherein the composition undergoes treatment for virus inactivation, wherein the composition comprises at least one stabilizer selected from the group consisting of glycine and proline, wherein the composition is formulated in a glycine- or proline-containing buffer at a pH in the range of from 4 to 5.5, and
• wherein the composition has an anticomplementary activity (ACA) of <1 CH50/mg protein, and
• wherein the content of IgG polymers in the composition after long-term storage at temperature of 25° C. over a period of 15 months is not more than 1.0%, determined by HPSEC, based on the total amount of IgG in the composition.