GC Biopharma Presents New Data at CIS 2026 to Expand Analytical Understanding of IVIG Product Characteristics

Research explored molecular and physical characteristics of IVIG products that may help inform scientific understanding relevant to clinical care and product selection

TEANECK, N.J.--(BUSINESS WIRE)--GC Biopharma USA, Inc., a leader in plasma-derived products, announced today the presentation of new data at the 2026 Clinical Immunology Society (CIS) Annual Meeting in New Orleans, Louisiana. GC Biopharma’s presentations at CIS included two company-authored posters, one on molecular size distribution of ALYGLO^® (immune globulin intravenous, human-stwk, 10% liquid) following mechanical stress and one on viscosity across intravenous immunoglobulin (IVIG) products. A third poster supported through GC Biopharma’s Investigator-Initiated Research Program includes an initial in silico evaluation of contaminant protein signatures and predicted immunogenicity-related differences across four commercially available IVIG products.

“We’re proud to have supported research which was presented at a leading meeting in clinical immunology whose focus is to foster education, translational research, and novel approaches to patient care,” said Stacey Ness, PharmD, IgCP, CSP, MSCS, AAHIVP, Medical Science Liaison, Medical Affairs, GC Biopharma USA. “Together, our company-led research and supported external research contribute to broader scientific understanding of the molecular and physical characteristics of IVIG products. As immunoglobulin utilization continues to increase, these studies may help inform scientific evaluation, including considerations relevant to clinical care and product selection.”

GC Biopharma presented two studies at CIS examining molecular and physical characteristics of IVIG products. The first presentation evaluated the impact of controlled mechanical agitation on the molecular size distribution of ALYGLO. The analysis described how molecular size distribution was assessed over time using size-exclusion high-performance liquid chromatography following agitation under defined laboratory conditions. The study concluded that mechanical agitation under the tested conditions had minimal impact on molecular size distribution, with a very high percentage of monomers and dimers remaining throughout the duration of the study, compared to polymers and fragments below quantifiable limits. The study also noted that further assessment under conditions more analogous to real-world settings is warranted.

A second GC Biopharma study examined the viscosity of commercial IG preparations. All products showed consistent, sequential decreases in viscosity as temperatures increased, suggesting that room temperature (25° C) infusions could help mitigate viscosity-related risk.

In addition, a study supported through GC Biopharma’s Investigator-Initiated Research Program described an in silico analytical approach to evaluating product-specific human contaminant protein signatures across commercial IVIG products. Using the ISPRI-HCP platform, the analysis compared contaminant protein burden and predicted immunogenicity-related characteristics across products. The authors concluded that in silico screening of contaminant protein signatures may help identify product-specific immunogenicity drivers and inform future IVIG product optimization.

GC Biopharma also hosted a lunch symposium at CIS, titled “From Molecules to Tolerability: Understanding Immunoglobulins and Immunogenicity Through Advanced Molecular Characterization,” presented by Kevin Van Cott, Ph.D., Associate Professor in the Department of Chemical and Biomolecular Engineering at the University of Nebraska-Lincoln and Annie De Groot, M.D., Founder, EpiVax, Inc. and Founder and President of EVA Therapeutics. The speakers discussed how advanced protein characterization and immunogenicity assessment may broaden scientific understanding of intravenous immunoglobulin products and their attributes.

As a company with more than 50 years of expertise in plasma protein manufacturing, GC Biopharma is committed to advancing scientific understanding of IVIG therapies and supporting research that may help inform patient care.

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 (e.g., 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.