Process for obtaining an IgG composition through heat treatment

摘要

A process for obtaining an IgG composition involves heat treatment. This process obtains an IgG composition from an IgG solution partly purified from human plasma, in which by applying intermediate heat treatment and without using reagents to precipitate high molecular weight aggregates/polymers and/or proteins virtually total elimination of the IgG polymers generated during the process is achieved. Furthermore this process offers high productivity, lower production costs and is easy to implement in comparison with the processes of the know art. In addition to this, by using this process stability is imparted to the final product in liquid.

主权项

1. A process for obtaining a liquid IgG composition from an IgG solution partly purified from human plasma, comprising the steps of:
a) diafiltering the partly purified IgG solution; b) stabilising the solution obtained in step a); c) heat treating the solution obtained in step b) whereby no more than 3% high molecular weigh aggregates and polymers are generated; d) selectively adsorbing at least 85% of the high molecular weight aggregates and polymers in step c) by cation exchange chromatography; and e) diafiltering the solution obtained in step d), whereby the liquid IgG composition is obtained , wherein the liquid IgG composition is stable for at least 1 year at a temperature of 2-30° C. and a pH of 4.6-5.8.