Isoagglutinin Removal
Isoagglutinins are natural antibodies that interact with Type A and Type B blood group antigens found on the surface of red blood cells, determining ABO blood types in humans. People with Type A, Type B, and Type O blood typically have isoagglutinin antibodies in their blood or plasma. Since IVIG (intravenous immunoglobulin) is produced from large pools of plasma donated by numerous individuals, IVIG batches often contain measurable levels of isoagglutinins. The presence of isoagglutinins in therapeutic plasma products raises significant concerns due to the potential for severe hemagglutination reactions. Consequently, strict limits are set on the maximum isoagglutinin titers allowed in these products, with regulatory mandates to reduce these levels to very low thresholds.
Isoagglutinin depletion with IsoClear® Resins
Astrea Bioseparations’
IsoClear® resins feature Type A or Type B blood group antigens immobilized on an inert resin support, designed for high affinity binding to isoagglutinin antibodies. These resins offer substantial isoagglutinin binding capacities, effectively reducing isoagglutinin titers to very low levels. Manufactured to high quality standards, IsoClear® resins come with comprehensive regulatory support and have proven effectiveness in plasma product manufacturing. IsoClear® resins are an optimal solution for meeting the requirements of plasma product manufacturing.
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