Presentations describe molecular size distribution of ALYGLO® after mechanical stress, as well as cross-product analyses of viscosity and immunogenicity-related contaminant protein profiles
TEANECK, N.J.--(BUSINESS WIRE)--GC Biopharma USA, Inc., a leader in plasma-derived products, announced today that it will host a lunch symposium and support three scientific presentations at the 2026 Clinical Immunology Society (CIS) Annual Meeting, taking place May 6 to 9 in New Orleans, Louisiana. GC Biopharma’s presentations at CIS will include two company-authored posters and one EpiVax-led poster supported through GC Biopharma’s Investigator-Initiated Research Program.
GC Biopharma’s two posters will present research on molecular size distribution of ALYGLO® (immune globulin intravenous, human-stwk, 10% liquid) following mechanical stress and on viscosity across IVIG products. The EpiVax-led poster will present an initial in silico evaluation of contaminant protein signatures and predicted immunogenicity-related differences across four commercially available IVIG products.
“These presentations reflect GC Biopharma’s commitment to advancing scientific understanding of IVIG characterization through both company-led research and support for externally led studies that explore complementary product attributes,” said Stacey Ness, PharmD, IgCP, CSP, MSCS, AAHIVP, Medical Science Liaison, Medical Affairs, GC Biopharma USA. “Together, they represent several approaches to characterizing IVIG products with potential relevance to clinical practice.”
GC Biopharma’s lunch symposium, titled “From Molecules to Tolerability: Understanding Immunoglobulins and Immunogenicity Through Advanced Molecular Characterization,” will take place on Friday, May 8, from 1:10 p.m. to 2:10 p.m. CT. The session will bring together expertise in advanced protein characterization and immunogenicity assessment to explore how analytical methods may deepen scientific understanding of immunoglobulin products. The speakers for this session will be:
- Kevin Van Cott, Ph.D., Associate Professor in the Department of Chemical and Biomolecular Engineering at the University of Nebraska-Lincoln, whose work focuses on advanced protein characterization and contaminant analysis in biopharmaceuticals, and
- Annie De Groot, M.D., Founder, EpiVax, Inc., and Founder and President of EVA Therapeutics, whose work has helped advance understanding of immunogenicity and in silico risk assessment.
Poster presentations at CIS will include two studies conducted by GC Biopharma and one externally led study from EpiVax supported through GC Biopharma’s Investigator-Initiated Research Program:
Title: Foundational Analysis of the Impact of Mechanical Stress on Molecular Size Distribution in Immune Globulin Intravenous, Human-stwk, 10%
Presenter: Stacey Ness, PharmD, IgCP, CSP, MSCS, AAHIVP, Medical Affairs, GC Biopharma USA
Day & Time: Thursday, May 7, 2026, 1:30 to 2:30 p.m. CT
Title: Investigation Into the Viscosity of Commercial IG Preparations
Presenter: Suzanne Strasters, MSN, FNP-C, IgCN, Medical Affairs, GC Biopharma USA
Day & Time: Thursday, May 7, 2026, 1:30 to 2:30 p.m. CT
Title: In Silico Hypersensitivity Risk Assessment of Product-Specific Human Contaminant Proteins in Commercial IVIG Products
Presenter: Benjamin Gabriel, Ph.D., Research Scientist, EpiVax, Inc.
Day & Time: Friday, May 8, 2026, 2:10 to 3:10 p.m. CT
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
|
- 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 medicalinfo@gcbiopharmausa.com. 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.
Contacts
