Biological Safety of a Highly Purified 10% Liquid Intravenous Immunoglobulin Preparation from Human Plasma

BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Caroline GoussenBenoît Flan

Abstract

A highly purified 10% liquid intravenous immunoglobulin, IQYMUNE®, has been developed using an innovative manufacturing process including an affinity chromatography step for the removal of anti-A and anti-B hemagglutinins. The pathogen (viruses and prions) clearance efficacy of the manufacturing process and its robustness for critical steps were investigated. The manufacturing process of IQYMUNE®includes two dedicated complementary virus reduction steps: solvent/detergent (S/D) treatment and 20 nm nanofiltration as well as two contributing steps, namely caprylic acid fractionation and anion-exchange chromatography. The clearance capacity and robustness of these steps were evaluated with a wide range of viruses (enveloped and non-enveloped) and with a model of human transmissible spongiform encephalopathies (TSEs). The IQYMUNE®manufacturing process demonstrated a high and robust virus removal capacity with global reduction factors (RFs) of relevant and model viruses: ≥14.8 log10for human immunodeficiency virus type 1 (HIV-1), ≥16.9 log10for bovine viral diarrhoea virus (BVDV)/Sindbis virus, ≥15.7 log10for pseudorabies virus (PRV), ≥12.8 log10for encephalomyocarditis virus (EMCV) and 11.0 log10for porcine parvovirus (PPV). The pr...Continue Reading

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Methods Mentioned

BETA
Affinity Chromatography

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