Abstract
This study aims to characterize the intermediates, and the final product (FP) obtained during the production of human intramuscular hyperimmune gamma globulin anti-SARS-CoV-2 (hIHGG anti-SARS-CoV-2) and to determine its stability. Material and methods : hIHGG anti-SARS-CoV-2 was fractionated from 270 convalescent plasma donations with the Cohn method. Prior to fractionation, the plasma was inactivated (Theraflex MB Plasma). Samples were defined using enzyme immunoassays (EIA) for anti-S1, anti-RBD S1, and anti-N antibodies, and neutralization assays with SARS-CoV-2 (VN) and pseudoviruses (PVN, decorated with SARS-CoV-2 S protein). Results were expressed as a titer (EIA) or 50% of the neutralization titer (IC 50 ) estimated in a four-parameter nonlinear regression model. Results: Concentration of anti-S1 antibodies in plasma was similar before and after inactivation. Following fractionation, the anti-S1, anti-RBD, and anti-N (total tests) titers in FP were concentrated approximately 15-fold from 1:4 to 1:63 (1800 BAU/mL), 7-fold from 1:111 to 1:802 and from 1:13 to 1:88, respectively. During production, the IgA (anti-S1) antibody titer was reduced to an undetectable level and the IgM (anti-RBD) titer from 1:115 to 1:24. The neutralizing antibodies (nAb) titer increased in both VN (from 1:40 to 1:160) and PVN (IC 50 from 63 to 313). The concentration of specific IgG in the FP did not change significantly for 14 months. Conclusions: The hIHGG anti-SARS-CoV-2 was stable, with concentration up to approximately 15-fold nAb compared to the source plasma pool.
Keywords: COVID-19; SARS-CoV-2; convalescent plasma; gamma globulin; human intramuscular hyperimmune gamma globulin anti-SARS-CoV-2 (hIHGG anti-SARS-CoV-2).
【저자키워드】 COVID-19, convalescent plasma, SARS-CoV-2, gamma globulin, human intramuscular hyperimmune gamma globulin anti-SARS-CoV-2 (hIHGG anti-SARS-CoV-2)., 【초록키워드】 neutralizing antibody, IgG, IgM, antibody, anti-SARS-CoV-2, immunoassay, stability, Neutralization assay, IgA, inactivation, anti-N antibodies, Antibody titer, plasma, convalescent, inactivated, NAb, intramuscular, SARS-CoV-2 S protein, Concentration, anti-RBD, enzyme, Final, material, neutralization titer, hyperimmune, Result, defined, Sample, significantly, determine, were expressed, was reduced, four-parameter nonlinear regression, pseudovirus, undetectable, 【제목키워드】 Human, Gamma, Globulin, product, intermediate,