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Antibody Fc Functional Activity of Intravenous Immunoglobulin Preparations Treated with Solvent‐Detergent for Virus Inactivation

We report here results of in vitro comparisons of the Fc functional activity of a second‐generation intravenous immunoglobulin (IGIV) preparation (Venoglobulin®‐I) and a third‐generation IGIV product that includes a deliberate virus‐inactivation step (Venoglobulin®‐S). Both formulations showed equivalent Fc‐mediated function against viral antigens (rubella, influenza A, and influenza B) by single‐radial hemolysis test, and against group B Streptococcus, Staphylococcus aureus and Escherichia coli by opsonophagocytosis assay. In addition, we showed by three different immunochemical reactions and by HPLC analysis that both preparations consisted of mostly monomeric IgG and contained very low levels of complement‐fixing IgG aggregates. However, IgG aggregation induced by heating at 63°C markedly enhanced fixation of C1q and C3 and binding to Raji cells, indicating that the IgG molecules retained their complement‐fixing capacity. Thus, the incorporation of a virus inactivation step in the manufacture of our third‐generation IGIV did not alter the Fc functional activities of the IgG, as measured by these in vitro assay systems.