New analyses include a multi-lot comparison of commercially available 10% IVIG products and additional characterization of selected safety outcomes from the Phase 3 ALYGLO® study
GC Biopharma will also host a patient advocacy symposium exploring global perspectives on advocacy and its impact on individual patients.
TEANECK, N.J.--(BUSINESS WIRE)--GC Biopharma USA, Inc., a leader in plasma-derived products, announced today that it will present two new analyses and host a patient advocacy symposium at the IgNS 2026 15th National Conference, taking place October 15–18 in Las Vegas, Nevada. The two poster presentations include an expanded multi-lot assessment of aggregation profiles across five commercially available 10% intravenous immunoglobulin (IVIG) products and a post hoc descriptive review of selected safety outcomes from the Phase 3 study of ALYGLO® (immune globulin intravenous, human-stwk, 10% liquid).
In the aggregation analysis, all five products demonstrated high purity and low aggregate levels, with statistically significant differences observed among the products. The Phase 3 analysis provides additional characterization of selected events of special interest (ESIs) based on the Clinical Study Report (CSR). No treatment-related thromboembolic events, acute renal failure, deaths, or adverse event-related discontinuations were observed.
“These analyses provide additional insight into both the characteristics of commercially available IVIG products and selected safety outcomes from the ALYGLO Phase 3 study,” said Stacey Ness, PharmD, IgCP, CSP, MSCS, AAHIVP, Medical Science Liaison, Medical Affairs, GC Biopharma USA. “Expanding the aggregation study across multiple lots strengthens our understanding of product-to-product differences, while the clinical study report analysis adds detail on events of special interest that were not fully characterized in the original publication.”
The expanded aggregation analysis evaluated six lots of ALYGLO and three lots each of four other commercially available 10% IVIG products. Statistically significant differences were observed among the products in monomer and dimer content, fragment content, and particle size. No statistically significant differences were observed in polymer levels or particle size dispersion. Further research is needed to determine the clinical relevance of the observed differences in aggregate attributes.
The second poster reports a post hoc, CSR-only descriptive review of selected ESIs and serious adverse events from the Phase 3 ALYGLO clinical trial. Treatment-emergent serious adverse events were reviewed as additional safety context using available subject-level and CSR-reported subgroup characteristics, including age, sex, and infusion schedule. The review found no clinically meaningful thromboembolic, renal, hematologic, blood chemistry, DAT/Coombs, or viral safety signals. However, subjects with a history of thromboembolism and kidney disease were excluded from the clinical trial, which may limit the generalizability of the findings to higher-risk populations.
The two posters will be presented during the IgNS poster session on Saturday, October 17, 2026, from 5:00 p.m. to 6:30 p.m. PDT.
- Expanded Assessment of the Aggregation Profile of Commercially Available Intravenous Immunoglobulin Products
- Safety in a Phase 3 Study of IVIG-stwk 10%: A Descriptive Review of Events of Special Interest (ESIs) and Serious Adverse Events (SAEs)
GC Biopharma will also host the symposium, “Advocacy Across Borders: Global Perspectives, Individual Impact,” on Saturday, October 17, from 7:30 a.m. to 9:00 a.m. PDT in the Summerlin Ballroom. Presenters include:
- Lynn H. Albizo, JD, Chief Public Policy Officer, Immune Deficiency Foundation
- Suzanne Strasters, MSN-FNP, IgCN, Head of Clinical Education, GC Biopharma USA
- Laura Remy-Martin, PhD, MPH, ACRP-CP, Field Medical Science Liaison, GC Biopharma USA
Albizo will discuss patient advocacy and public policy and their impact on people with immune deficiencies, drawing on her experience leading legislative and regulatory advocacy at the Immune Deficiency Foundation.
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, 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
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- 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 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.
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