Hyperimmune IgG and/or IgM compositions and method for preparing thereof and method for obtaining hyperimmune human plasma from a donor
The present disclosure refers to a liquid therapeutic hyperimmune globulin composition comprising human plasma-derived immunoglobulin G (IgG) having antibody titre between 250 and 2,500 per mg/mL of IgG and/or a SARS-CoV-2 neutralization activity (IC50 neutralization titer) between 1.5 and 15 per mg...
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Zusammenfassung: | The present disclosure refers to a liquid therapeutic hyperimmune globulin composition comprising human plasma-derived immunoglobulin G (IgG) having antibody titre between 250 and 2,500 per mg/mL of IgG and/or a SARS-CoV-2 neutralization activity (IC50 neutralization titer) between 1.5 and 15 per mg/mL of IgG for use in the treatment of coronavirus disease 2019 (COVID-19) in a patient in need thereof. It also refers to a liquid therapeutic or prophylactic hyperimmune immunoglobulin composition comprising human plasma-derived immunoglobulin M (IgM) having a SARS-CoV-2 titre between 2,000 and 17,000 and/or a SARS-CoV-2 neutralization activity (IC50 neutralization titre) between 200 and 70,000, methods for preparing thereof, and the use thereof for the treatment or prophylaxis of COVID-19. Finally, it also refers to a method for obtaining hyperimmune human plasma from a donor for use in the treatment of COVID-19. |
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