Hyperimmune immunoglobulins: Manufacturing technologies and safety procedures

Abstract

Instituto Grifols has developed two different sterile and ready to use anti-hepatitis B (anti-HB) enriched immunoglobulin concentrates: Niuliva® is a 5% intravenous immunoglobulin solution with 250 IU/ml anti-HB potency, and Gamma anti-hepatitis B Grifols® (Igantibe®in some countries) is a 16% intramuscular immunoglobulin solution with 200 IU/ml anti-HB potency. The production process includes careful plasma donor selection, analysis to discard specific markers of relevant viral infections in the individual donations and plasma pools and, in order to further increase the safety margin, steps aimed at eliminating potential pathogenic agents (e.g., pasteurization). Characterisation studies from both products showed high IgG purity (more than 99%) and an IgG subclass distribution similar to normal plasma. Other potential accompanying proteins (eg: IgA, IgM, albumin, transferrin, etc) were undetectable or very low. Results from additional parameters (identification, total protein, molecular distribution, etc.) meet European Pharmacopoeia's requirements. The stability profile indicates that the products are stable between 2°C and 8°C for two years (Gamma anti-hepatitis B Grifols®) or three years (Niuliva®), maintaining the anti-HB potency.