IMMUNOGLOBULIN-CONTAINING COMPOSITION CONTAINING AN AGGREGATION PREVENTING OR AGGREGATE DISSOCIATING AGENT FOR THE IMMUNOGLOBULIN, AND PROCESS FOR PREPARATION THEREOF

摘要

Known compositions comprising an immunoglubulin, and an aggregation preventing or an aggregate dissociating agent for the immunoglobulin suffer from various problems such as immunoglobulin denaturation or decomposition. The problems are now overcome by using, as such an agent, 1 to 600% by weight, based on the weight of the immunoglobulin, of a water-soluble acid addition salt of a basic nitrogen-containing organic compound containing one or more basic nitrogen atoms in the molecule and having a pKb at 25 DEG C of not more than 7. Compositions containing a high proportion of monomeric immunoglobulin are obtained which can be used for intravenous administration of the immunoglobulin or can be lyophilized.