Immunoglobulin composition of three commercially available intravenous immunoglobulin preparations

To evaluate whether significant differences in immunoglobulin composition exist among the three commercially available intravenous immunoglobulin (IVIG) preparations, we compared three of these products in terms of their quantitative immunoglobulin concentration, IgG subclass concentration, and the presence of IgG aggregates. Three different lots were tested for each of the IVIG formulations, and the IgG subclass assays were performed by three different laboratories. Differences were found among the three formulations in subclass concentration and aggregate content. Sandoglobulin (Sandoz Pharmaceuticals, East Hanover, N.J.) contained a significantly higher amount of IgG2 (p less than 0.002) compared to the other formulations. All the formulations tested were found to be deficient in IgG4 relative to the World Health Organization standards, with Gammagard (Hyland Therapeutics, Glendale, Calif.) demonstrating only negligible amounts. Immunoglobulin aggregate content was different among manufacturers with Gamimmune N (Cutter Biological, Berkeley, Calif.) containing the highest amount of monomer IgG (99.8%). Significant differences were found in the subclass results obtained by the ICN ImmunoBiologicals assay (Lisle, Ill.), compared to the two reference laboratories. This difference among the subclass assays raises the question as to the use of these assays in the evaluation of patients with suspected subclass deficiencies. The differences in subclass concentration and aggregate content in IVIG preparations were great, and future clinical trials with these formulations would be indicated to determine the clinical significance of these findings.