Process for Preparing Immunoglobulin Compositions

A process for the preparation of pharmaceutically acceptable immunoglobulin compositions from a plasma-derived immunoglobulin fraction comprising or consisting of Cohn fraction I/II/III or Kistler-Nitschmann fraction A+I, said process comprising the steps of:

• (a) resolubilizing immunoglobulin contained in the plasma-derived immunoglobulin fraction comprising or consisting of Cohn fraction I/II/III or Kistler-Nitschmann fraction A+I by resuspending said plasma-derived immunoglobulin fraction under conditions to adjust the conductivity of the suspension to at least 1 mS/cm to obtain a suspension containing resolubilized IgG, IgM and IgA;
• (b) precipitating, and optionally adsorbing, contaminating protein in the suspension obtained in step (a) and removing said contaminating protein to obtain an impurity-depleted immunoglobulin composition;
• (c) subjecting the impurity depleted immunoglobulin composition obtained in step (b) to ion exchange chromatography using an anion exchange resin under conditions of pH and conductivity adjusted to substantially bind IgM and IgA and, optionally, IgG to the resin, and obtaining IgG-enriched immunoglobulin compositions in the flow-through fraction and/or by eluting IgG from the anion exchange resin under conditions where IgM and IgA remain bound to the anion exchange resin, optionally followed by eluting IgM and/or IgA from the anion exchange resin to obtain immunoglobulin compositions enriched in IgM- and/or IgA;
• and
• (d) subjecting the IgG-enriched immunoglobulin composition obtained in step (c) to treatment with a cation exchange material under conditions of pH and conductivity where properdin is bound to said cation exchange material, and recovering IgG to obtain an IgG-enriched immunoglobulin composition having a reduced properdin content.

An IgG-enriched pharmaceutical immunoglobulin composition obtained from blood plasma of 500 donors or more, wherein said composition has:

• (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) a content of IgG polymers of not more than 0.05%, based on the total amount of IgG in the composition.