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Stock Up & Save on Chromatography Resins - Learn More

Intravenous Immunoglobulin

Polyclonal Immunoglobulin G, isolated from pooled human plasma, is a commercially significant protein widely used in treating immunodeficiency diseases. While traditionally produced using cold ethanol precipitation (the Cohn Process), chromatographic methods are increasingly used in the purification of IVIG to achieve higher purities and recoveries. Given the highly regulated nature of these products and the origin of pooled human plasma, IVIG production often requires additional purification steps. Recently, there has been heightened regulatory focus on reducing the isoagglutinin titer of IVIG products. Astrea Bioseparations offers a variety of chromatography resins that are tailored for the commercial production of IVIG.
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    Capture and purification of IVIG with MAbsorbent® A2P HF

    Originally designed for monoclonal antibody purification, MAbsorbent® A2P HF, a robust and fully alkali-stable PuraBead®-based affinity resin, is also highly effective as a capture step for IVIG. The MAbsorbent® A2P ligand binds to the same region of IgG as Protein A, achieving similar purities and viral clearance, often with superior removal of antibody aggregates. Notably, unlike Protein A, MAbsorbent® A2P HF can bind all four subclasses of Human IgG, including IgG3, enhancing its suitability for IVIG production. Furthermore, it does not bind IgM and exhibits low affinity for IgA, making it particularly advantageous. This non-toxic, validated affinity resin, available in both normal and low-ligand (LL) densities to reduce non-specific binding without sacrificing capacity, is produced in large batch sizes and ideal for the commercial manufacture of therapeutic IVIG. MAbsorbent® A2P HF is an exceptionally capable resin for the selective capture and purification of IVIG. 

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    IVIG polishing using DEAE PuraBead® HF IEX

    Anion exchange chromatography using DEAE PuraBead® P6HF is an effective flow-through step for the secondary purification of IVIG, especially for removing residual IgA. Like all PuraBead® ion exchange resins, DEAE PuraBead® P6HF is an easy to clean, fully alkali-stable, near-monodisperse chromatographic adsorbent that offers high binding capacities, high flow rates, low back pressures, and extended operational lifetimes.

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    Isoagglutinin depletion with IsoClear® Resins

    Isoagglutinins are naturally occurring antibodies that interact with Type A and Type B blood group antigens on red blood cells, which determine ABO blood types in humans. These antibodies are typically present in the blood or plasma of individuals with Type A, Type B, and Type O blood groups. Since IVIG is produced from large pools of plasma donated by multiple individuals, it often contains significant levels of isoagglutinins. The presence of these antibodies in therapeutic plasma products poses a serious risk of hemagglutination reactions, leading to strict regulatory limits on isoagglutinin titers in these products, with pressure to reduce to minimal levels. Astrea Bioseparations' IsoClear® resins, which feature Type A or Type B blood group antigens immobilized on an inert resin support, have a high affinity for isoagglutinin antibodies and provide substantial isoagglutinin binding capacities, effectively reducing isoagglutinin titers to very low levels. Manufactured to high-quality standards with comprehensive regulatory support and validated in plasma product manufacturing applications, IsoClear® resins offer an optimal solution for IVIG manufacturing. 

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