GC Biopharma Announces Presentation on Aggregation Profiles of Commercial IVIG Products at NHIA 2026

• Research highlights molecular size distribution and particle characteristics across commercially available intravenous immunoglobulin (IVIG) products
• Protein aggregation in IVIG preparations may influence immunogenicity, stability, and infusion tolerability, underscoring the importance of controlling impurities and aggregation during IVIG manufacturing

TEANECK, N.J.--(BUSINESS WIRE)--GC Biopharma USA, Inc., 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.

The poster, “Assessment of the Aggregation Profile of Commercially Available Intravenous Immunoglobulin Products,” will be presented on Monday, April 20, 2026, from 1:00 p.m. to 2:30 p.m. in the NHIA Expo Hall.

About ALYGLO^®

ALYGLO^® (immune globulin intravenous, human-stwk) is a glycine-stabilized 10% immunoglobulin G (100 mg/mL) for intravenous infusion, manufactured from pooled human plasma from US donors. The manufacturing process includes multiple steps to reduce the risk of virus transmission. These include solvent/detergent treatment and 20 nm nanofiltration. The ALYGLO manufacturing process also uses G-XI^™ Technology, its novel cation exchange (CEX) chromatography process, that removes FXIa to undetectable levels.^1,2 For more information about ALYGLO and G-XI™ Technology, visit www.alyglo.com.

About GC Biopharma

GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers lifesaving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma is a leading global plasma protein and vaccine product manufacturer dedicated to quality healthcare solutions for over half a century.

About GC Biopharma USA

GC Biopharma USA, headquartered in Teaneck, NJ, is an operations and distribution company of GC Biopharma, that established its sales, marketing, and business operations in 2018 to serve customers and patients throughout the US. Our foundation is built on the expertise of our parent company GC Biopharma, a leading biopharmaceutical company delivering plasma therapies and vaccines worldwide for more than 50 years. With GC Biopharma USA, GC Biopharma further extends its footprint, bringing its expertise and legacy to the US. For more information, visit www.gcbiopharma.us.

INDICATION

ALYGLO^® is indicated for the treatment of primary humoral immunodeficiency (PI) in adults aged 17 years and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE Thrombosis may occur with immune globulin intravenous (IGIV) products, including ALYGLO. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ALYGLO does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or renal failure, administer ALYGLO at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

• Contraindications: ALYGLO is contraindicated in patients who have a history of anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.
• Hypersensitivity: In case of hypersensitivity, discontinue infusion immediately and institute appropriate treatment. Epinephrine should be available for immediate treatment of severe acute hypersensitivity reactions.
• Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia: Hyperproteinemia, increased serum viscosity, and hyponatremia may occur.
• Aseptic Meningitis Syndrome (AMS): Aseptic meningitis syndrome (AMS) may occur, especially with high doses or rapid infusion. AMS usually begins within several hours to 2 days following ALYGLO treatment. Discontinuation of treatment has resulted in remission of AMS within several days without sequelae.
• Hemolysis: Delayed hemolytic anemia due to enhanced red blood cell (RBC) sequestration and acute hemolysis consistent with intravascular hemolysis have been reported. Cases of severe hemolysis-related renal dysfunction/failure or disseminated intravascular coagulation have occurred following infusion of IGIV. Closely monitor patients for clinical signs and symptoms of hemolysis, particularly patients with risk factors.
• Transfusion-Related Acute Lung Injury: Noncardiogenic pulmonary edema (transfusion-related acute lung injury [TRALI]) may occur. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Patients with TRALI may be managed using oxygen therapy with adequate ventilator support. Monitor patients for pulmonary adverse reactions.
• Transmissible Infectious Agents: Because ALYGLO is made from human blood, it may carry a risk of transmitting infectious agents (eg, viruses, the variant Creutzfeldt-Jakob disease [vCJD] agent and, theoretically, the Creutzfeldt-Jakob disease [CJD] agent).
• Interference with Laboratory Tests: After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for a misleading interpretation.
• Adverse reactions (observed in ≥ 5% of study subjects) were headache, nausea/vomiting, fatigue, nasal/sinus congestion, rash, arthralgia, diarrhea, muscle pain/aches, infusion site pain/swelling, abdominal pain/discomfort, cough, and dizziness.
• It is recommended that ALYGLO be administered separately from other drugs or medications.

Please see Important Safety Information for ALYGLO on the preceding pages and refer to the full Prescribing Information (PI) or visit Alyglo.com.

If you have an inquiry related to drug safety, or to report adverse events, please contact GC Biopharma USA at 1-833-426-6426 or email [e-mail]. You can also visit FDA.gov/medwatch or call 1-800-FDA-1088.

This press release may contain forward-looking statements that express the current beliefs and expectations of the management at GC Biopharma and GC Biopharma USA. Such views do not represent any guarantee by either entity or its government of future performance and involve known and unknown risks, uncertainties, and other factors. GC Biopharma and GC Biopharma USA undertake no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements they may make, except as required by law or stock exchange rule.

References: 1. Kang GB, Huber A, Lee J, et al. Cation exchange chromatography removes FXIa from a 10% intravenous immunoglobulin preparation. Front Cardiovasc Med. 2023;10:1253177. 2. ALYGLO Prescribing Information. GC Biopharma; 2025.