Manufacture of Immunoglobulin Products for Patients with Primary Antibody Deficiencies – The Effect of Processing Conditions on Product Safety and Efficacy

• Published in: Frontiers in immunology Vol. 5; p. 665
• Main Authors: Farrugia, Albert, Quinti, Isabella
• Format: Journal Article
• Language: English
• Published: Switzerland Frontiers Media S.A 23.12.2014
• Subjects: Hemolysis; Immunoglobulins; Immunology; manufacturing technology; Safety; Thrombosis; manufacturing technology; thrombosis; immunoglobulins; safety; hemolysis

Early preparations of immunoglobulin (Ig) manufactured from human plasma by ethanol (Cohn) fractionation were limited in their usefulness for substitution therapy in patients with primary antibody deficiencies (PAD), as Ig aggregates formed during manufacture resulted in severe systemic reactions in...