Characterization of antibodies in human immunoglobulin products from different regions worldwide

Abstract

Aim: 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 10 countries/regions. Depending on each pathogen, antibody levels were measured using specific commercial IgG-specific enzyme immunoassay kits or by cell culture neutralization test and guinea pig skin neutralization test. A principal component analysis was performed.

Results: For polio and diphtheria (reference markers of the US authorities), all IVIGs had relevant titers in accordance with reference levels. IVIGs from Canada, Australia, and the USA were positive for titers against globally distributed pathogens or those under vaccination programs in the developed world (parainfluenza, Epstein-Barr, varicella-zoster, influenza B, parvovirus B19, and measles viruses). IVIG from Taiwan and Hong Kong showed low antibody titers for these pathogens but high titers for Pseudomonas aeruginosa. IVIG from India had high titers for pathogens frequently found in developing countries (West Nile, dengue, chikungunya, and hepatitis E viruses and Streptococcus 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 the prevalence of pathogens in the different countries and regions.

Keywords: Antibody titer; Blood plasma; Intravenous immunoglobulin.

Figure 1

Principal component analysis (PCA) plot of the first two components, showing a clear separation of four groups of intravenous immunoglobulin preparations based on their antibody titers. Percentages of variation explained by each component are indicated along the axes. Argentina (ARG), Australia (AUS), Taiwan (TWN), Hong Kong (HKG), India (IND), Israel (ISR), Spain (SPN), Czechia (CZE), United States of America (USA), and Canada (CDA).