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Intravenous Immunoglobulin

Polyclonal Immunoglobulin G (IVIG), isolated from pooled human plasma, is a commercially significant therapeutic used worldwide in the treatment of primary and secondary immunodeficiency diseases, as well as in a growing number of autoimmune and inflammatory conditions. With a global market that continues to expand, IVIG remains one of the most valuable plasma-derived medicines. Traditionally, IVIG has been manufactured through cold ethanol fractionation, commonly known as the Cohn Process, which separates plasma proteins based on differential solubility. While this method has formed the backbone of large-scale IVIG production for decades, it has inherent limitations in yield, selectivity, and process efficiency.

In response, modern manufacturers are increasingly adopting chromatographic methods to improve both recovery and purity. Chromatography enables finer control over separation, enhanced reproducibility, and the ability to design purification workflows that address specific regulatory requirements. Given the complex origin of IVIG-derived from large pools of human plasma—stringent purification and viral clearance steps are essential to ensure product safety and consistency. Regulatory authorities also continue to increase scrutiny on product quality, with particular focus on reducing isoagglutinin titers, which are antibodies within IVIG that can cause hemolytic reactions. Meeting these standards requires robust, scalable, and selective purification technologies capable of delivering consistent quality across large manufacturing campaigns.

Astrea Bioseparations offers a portfolio of chromatography resins specifically designed to support IVIG production. These include mixed-mode, ion exchange, and affinity resins that can be integrated into plasma fractionation processes to enhance selectivity, reduce impurities such as isoagglutinins, and improve overall process efficiency. With their scalability, chemical stability, and proven performance in plasma-derived workflows, Astrea’s resins provide manufacturers with flexible solutions to meet both current and emerging challenges in IVIG purification, helping ensure that patients worldwide receive safe and effective therapies.

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Our Solutions

    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,  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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    MiMode™ PuraBead® HL3

    MiMode™ PuraBead® HL3 is a targeted mixed-mode affinity resin effective in the capture of polyclonal immunoglobulins. The ligand binds specifically to the Fc region of IgG, enabling efficient capture of all subclasses present in IVIG preparations. With its low-ligand (LL) density design,  minimizes non-specific interactions while preserving high capacity, delivering clean separations without compromising yield. Built on the robust PuraBead® matrix, MiMode™ PuraBead® HL3 provides a reliable and scalable solution for the selective purification of IVIG in commercial manufacturing.

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    IsoClear® XT

    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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    DEAE PuraBead®

    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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    MiMode™ PuraBead® CBX1

    In plasma-derived therapeutics, immunoglobulins are naturally glycosylated proteins, with their glycan structures playing a critical role in stability and biological activity. The ability to selectively isolate these glycosylated forms is therefore central to both manufacturing and quality control. MiMode™ PuraBead® CBX1 provides a powerful solution for this need: as shown in our application note, the resin effectively captures glycosylated polyclonal IgG from plasma using reversible boronate–diol interactions, with gentle sorbitol elution preserving antibody integrity and delivering highly pure fractions. This makes  MiMode™ PuraBead® CBX1 a robust and scalable tool for enriching therapeutic immunoglobulins, ensuring consistency in plasma processing workflows and supporting applications ranging from IVIG production to analytical glycoprotein studies

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