A leader in plasma-derived products, today announced the presentation of new research evaluating the aggregation profiles, including molecular size distribution and particle size, in commercially available intravenous immunoglobulin (IVIG) products. The data will be presented at the 2026 National Home Infusion Association (NHIA) Annual Conference, taking place April 18–22, in Denver, Colorado.
Global demand for IVIG has increased steadily due to improved recognition of primary immunodeficiencies and broader use in immune-mediated conditions. As utilization expands, manufacturing processes must balance immunoglobulin yield with product purity, stability, and safety. Protein aggregates are an important consideration in IVIG products, as they may influence immunogenicity, stability, and infusion-related reactions, highlighting the importance of monitoring impurities and aggregation during manufacturing.
“Immunoglobulin therapy is the gold standard for the treatment of primary immunodeficiency and other immune-mediated conditions,” said Alan Huber, PharmD, Director of Medical Affairs at GC Biopharma USA. “As demand for immunoglobulin therapy continues to grow with improved disease recognition, analytical characterization of IVIG preparations helps advance scientific understanding of the molecular properties of these therapies.”
In this analysis, ALYGLO® (immune globulin intravenous, human-stwk, 10% liquid) was evaluated alongside four other commercially available 10% IVIG products to characterize molecular size distribution and particle properties associated with protein aggregation. The data showed that the ALYGLO purification process resulted in an aggregation profile with a high percentage of monomers and dimers compared to low amounts of polymers and fragments. These findings contribute to the ongoing scientific evaluation of IVIG product characteristics and may help inform product selection strategies aimed at reducing immunogenicity associated with protein aggregates for patients receiving IVIG therapy.
“These findings add to the ongoing characterization of IVIG preparations and provide additional analytical information on molecular size distribution and particle characteristics that may be relevant to IVIG preparation and administration,” said Stacey Ness, PharmD, IgCP, CSP, MSCS, AAHIVP, Medical Science Liaison, Medical Affairs, GC Biopharma USA. “As more patients receive IVIG therapy in home settings, GC Biopharma values the opportunity to engage with home infusion providers on the latest research and advances that support safe administration and high-quality patient care.”
As a company with more than 50 years of expertise in plasma protein manufacturing, GC Biopharma is committed to elevating standards in IVIG therapies. To support control of plasma-derived impurities and protein aggregation, ALYGLO is produced using an enhanced purification process that includes cold ethanol fractionation, ultrafiltration/diafiltration, anion-exchange chromatography, solvent/detergent viral inactivation, cation-exchange chromatography, nanofiltration, and additional ultrafiltration steps prior to final formulation.
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