Gammaglobulin preparations

Commercial preparations of gammaglobulin, usually obtained from pooled plasma from 500-2000 or more donors by the Cohn-Oncley process, contains approximately 85% IgG, 10% IgM, 5% IgA and traces of other plasma proteins. The immunoglobulin concentrates contain the majority of antibodies of the IgG class present in the starting plasma. Two main forms of these immunoglobulin concentrates are available: a 15% solution intended for intramuscular (or subcutaneous) use, and lyophilized powders or liquids intended for intravenous use. The former often contains 8-20 /u.g ml 1 thiomersal, as the solution is packaged in multidose vials; it also contains immunoglobulin aggregates which make it unacceptable for intravenous use. The lyophilized powders and liquids for intravenous use contain no preservatives.

Intravenous infusion of gammaglobulin concentrates (initially the fraction II of the Cohn-Oncley "process) was first attempted in the 1950s. Unfortunately, these infusions resulted in severe reactions in a number of instances, probably because of complement activation due to the infusion of aggregates. However, over time, various methods of modifying the immunoglobulin solutions were devised to produce products suitable for intravenous use. These methods included: enzymatic treatment of immunoglobulin; addition of chemical groups to prevent aggregation; reduction, sulfonation, or reduction followed by alkylation; addition of stabilizers (maltose, sucrose, albumin, glycine, mannitol); ion exchange column filtration; and precipitation of aggregates by polyethylene glycol.

The best method of preparation of intravenous immunoglobulin has not been established, and no comparative trials have been performed to compare the types available. Any method that produces an immunoglobulin concentrate containing intact and unmodified immunoglobulin in a form suitable for intravenous administration might be potentially satisfactory. Since enzyme-treated or reduced and alkylated immunoglobulin has reduced effector functions in terms of opsonic capacity or fixation of complement, these preparative methods are no longer favored. There is also a general consensus that these concentrates should contain IgG subclasses in the approximate proportions present in normal plasma and that no preservatives be added.

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