Publications by authors named "Adriano Marques Antunes"
Article Synopsis
- Hemolysis is a rare but serious risk linked to IVIG therapy due to antibodies to blood groups A and B, and an immunoaffinity chromatography (IAC) step can potentially lower these antibodies.
- Objectives included comparing isoagglutinin levels in IVIG produced with and without IAC and determining if IAC could be scaled for industrial production.
- Results showed that IAC significantly reduced isoagglutinin levels in IVIG while maintaining overall product quality, confirming its effectiveness and feasibility for large-scale manufacturing.
Background: Hemolysis reaction is a rare class effect of therapy with intravenously administered human normal immunoglobulin (IVIG). Anti-A/B isoagglutinins (isohemagglutinins) originating from donor plasma are considered a probable risk factor for hemolysis. We hypothesized that screening and exclusion of plasma obtained from donors with high isoagglutinin titers from the manufacturing process would produce a meaningful reduction of anti-A/B isoagglutinin titers of the final IVIG product.
View Article and Find Full Text PDFBackground: The passive transfer of antibodies specific to blood groups A and B (also called isoagglutinins) contained in immunoglobulin (Ig)G products for intravenous administration (IVIG) is believed to be largely responsible for rare but sometimes serious IVIG-related hemolytic events. We present in this work a modification of the manufacturing process of Privigen-a 10% l-proline-stabilized IVIG product-that allows extensive reduction of isoagglutinin concentrations in the final product.
Study Design And Methods: An additional immunoaffinity chromatography (IAC) step was introduced toward the end of the manufacturing process of Privigen.