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A Microassay for Measurement of Fc Function of Human Immunoglobulin Preparations using Tetanus Toxoid as Antigen

To minimize possible adverse reactions the functional integrity of proteins in products derived from human plasma has to be unaffected by methods of preparation and storage conditions. Numerous biologically relevant functions of IgG, major component of immunoglobulin for intravenous use preparations (IVIG), rely on the integrity of Fc fragments. Manufacturers are obliged to prove that Fc-mediated functions are maintained in IVIG preparations. European Pharmacopoeia monograph proposes a rubella antigen based test for Fc function of immunoglobulins. Here we present a modification of the proposed method achieved by using more convenient and readily available tetanus toxoid as alternative antigen target and by adapting the procedure for use on microtitre plates thus greatly enhancing its feasibility and sample throughput. The test conditions were optimized so that batch-to-batch variability in tetanus antibody content does not influence the result. Precision of the test was within &plusmn ; ; ; ; ; ; ; ; 5%. Using this test we compared Fc-functionality of 9 commercial IVIG-7S preparations prepared using different virus inactivation/removal approaches and found no significant differences between them.

Human immunoglobulin; Fc Function

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