Characterization of antibodies in human immunoglobulin products from different regions worldwide

Serra, Alexandra; Marzo, Nuria; Pons, Berta; Maduell, Pau; López, Maite; Grancha, Salvador

PURPOSE: The antibody levels against a broad spectrum of pathogens were assessed in commercial intravenous immunoglobulin (IVIG) manufactured from pooled plasma obtained from different global regions. METHODS: Twenty-four IVIG commercial lots from eight manufacturers corresponding to 12 brands were analyzed. The plasma was collected in ten countries/regions. Depending on each pathogen, antibody levels were measured by specific commercial IgG-specific immunoenzymatic assay kits or cell culture neutralization test and guinea-pig skin neutralization test. A principal component analysis was performed. RESULTS: For polio and diphtheria (reference markers by US Authorities) all IVIGs had relevant titers in accordance with reference levels. IVIGs from Canada, Australia and USA were positive for titers against globally distributed pathogens or those under vaccination programs in developed world (parainfluenza, Epstein-Barr, varicella-zoster, influenza-B, parvovirus-B19, measles). IVIG from Taiwan and Hong-Kong showed low antibody titers for these pathogens but high titers forP. aeruginosa. IVIG from India had high titers for pathogens frequently found in developing countries (West Nile, dengue, chikungunya, hepatitis-E, S. pneumoniae). IVIGs from Argentina, Spain, Israel and Czechia showed intermediate antibody concentrations. CONCLUSION: The antibody profile in IVIG was greatly influenced by regional characteristics including climate, vaccination programs and prevalence of pathogens in the different countries and regions.