Characterization of antibodies in human immunoglobulin products from different regions worldwide

Abstract

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.

Antibody response after COVID‐19 vaccination in intravenous immunoglobulin‐treated immune neuropathies

“…Also, all threshold levels for antibody positivity were well established by earlier studies [21, 23, 24]. A shorter manufacturing process or, as demonstrated for other pathogens [25], the acquisition of plasma from COVID‐19 high‐incidence regions resulting in more anti‐SARS‐CoV‐2‐seropositive donors could explain anti‐SARS‐CoV‐2 IgG‐positive IVIg. Because anti‐SARS‐CoV‐2 seropositivity is increasing worldwide [26], we anticipate that also the number of IVIg and SCIg lots containing anti‐SARS‐CoV‐2 IgG will rise in the future.…”

Polyvalent human immunoglobulin for infectious diseases: Potential to circumvent antimicrobial resistance

“…Nevertheless, there is an intrinsic lot-to-lot variability in the antibodies present in IVIG that depends, in turn, on the microbes that the plasma donors face during natural infections or vaccination (105); consequently, this variability in the antibody specificities depends on the regions from which donors are selected (106)(107)(108)(109). Therefore, a potential constraint for the specific use of IVIG may be that a specific preparation of IVIG does not contain enough titers of antibodies against the target microbe.…”

Challenges for Plasma-Derived Medicinal Products

“…The normal blood level for the clotting factor VIII (FVIII) is 100% with a range of 60–150% according to different factors such as genetic and environmental factors, blood group, disease, and stress response to injury. The normal immunoglobulin (IgG) level ranges between 7 and 16 g/L and the antibody profile depends on race, epidemiology of endogenous diseases, climate, vaccination programs, and prevalence of pathogens in different countries and regions [ 2 ]. The absence, deficiency, or dysfunction of a particular plasma protein can impair the homeostasis of the human body and be life threatening or disabling.…”