TEANECK, N.J., Oct. 13, 2025 /PRNewswire/ — GC Biopharma USA, Inc., a pacesetter in plasma-derived merchandise, participated because the unique Science to Options Associate on the 2025 Consortium of Unbiased Immunology Clinics (CIIC) Fall Convention, held September 26-28 in Tampa, Florida. The CIIC Fall Convention helps data-driven dialogue and collaboration amongst impartial immunology practices, making a discussion board to attach scientific development with real-world decision-making in IVIG and affected person care.
As a part of this system, Suzanne Strasters, MSN, FNP-C, IgCN, Head of Scientific Training, Medical Affairs, GC Biopharma USA, offered on the corporate’s product pipeline and its Investigator-Initiated Analysis (IIR) Program, highlighting GC Biopharma’s dedication to supporting impartial analysis that expands medical and scientific data in immunoglobulin therapies.
“Being the Science to Options associate at CIIC displays GC Biopharma’s dedication to schooling, collaboration, and supporting clinicians in delivering high-quality affected person care,” mentioned Strasters. “By means of initiatives like our IIR program, we intention to empower healthcare professionals and investigators to drive the subsequent wave of insights within the therapy of main immunodeficiencies.”
The CIIC Fall Convention is designed to foster significant scientific conversations in small-group settings, with restricted sponsor presence, making it a novel venue for collaborative engagement between trade and observe leaders.
With greater than 50 years of experience in plasma protein manufacturing, GC Biopharma is dedicated to elevating requirements in IVIG therapies. GC Biopharma manufactures ALYGLO® with an extra step, G-XI™ Expertise, a cation trade (CEX) chromatography course of, that has been proven to scale back coagulation issue XIa (FXIa) to undetectable limits.1,2 It has been a longstanding purpose inside the immunoglobulin neighborhood to take away FXIa in manufacturing.
ALYGLO® is accepted by the U.S. Meals and Drug Administration (FDA) for the therapy of main humoral immunodeficiency (PI) in adults aged 17 and older. ALYGLO® is supported by GC Biopharma’s 50-year legacy in plasma product manufacturing with immune globulin therapies distributed in additional than 50 nations worldwide.
For extra details about ALYGLO and G-XI™ Expertise, go to www.alyglo.com.
For extra details about GC Biopharma’s ongoing packages, together with IIR assist, go to www.gcbiopharmausa.com.
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 course of consists of a number of steps to scale back the chance of virus transmission. These embody solvent/detergent therapy and 20 nm nanofiltration. The ALYGLO manufacturing course of additionally makes use of G-XI™ Expertise, its novel cation trade (CEX) chromatography course of, that removes FXIa to undetectable ranges.1,2
About GC Biopharma
GC Biopharma (previously often known as Inexperienced Cross Company) is a biopharmaceutical firm that delivers lifesaving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma is a number one world plasma protein and vaccine product producer devoted to high quality healthcare options for over half a century.
About GC Biopharma USA
GC Biopharma USA, headquartered in Teaneck, NJ, is an operations and distribution firm of GC Biopharma, that established its gross sales, advertising and marketing, and enterprise operations in 2018 to serve clients and sufferers all through the US. Our basis is constructed on the experience of our guardian firm GC Biopharma, a number one biopharmaceutical firm delivering plasma therapies and vaccines worldwide for greater than 50 years. With GC Biopharma USA, GC Biopharma additional extends its footprint, bringing its experience and legacy to the US.
INDICATION
ALYGLO® is indicated for the therapy of main humoral immunodeficiency (PI) in adults aged 17 years and older. This consists of, however just isn’t restricted to, congenital agammaglobulinemia, widespread variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and extreme mixed immunodeficiencies.
IMPORTANT SAFETY INFORMATION
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WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE
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- Contraindications: ALYGLO is contraindicated in sufferers who’ve a historical past of anaphylactic or extreme systemic response to the administration of human immune globulin and in IgA-deficient sufferers with antibodies to IgA and a historical past of hypersensitivity.
- Hypersensitivity: In case of hypersensitivity, discontinue infusion instantly and institute acceptable therapy. Epinephrine needs to be obtainable for fast therapy of extreme acute hypersensitivity reactions.
- Hyperproteinemia, Elevated Serum Viscosity, and Hyponatremia: Hyperproteinemia, elevated serum viscosity, and hyponatremia might happen.
- Aseptic Meningitis Syndrome (AMS): Aseptic meningitis syndrome (AMS) might happen, particularly with excessive doses or speedy infusion. AMS normally begins inside a number of hours to 2 days following ALYGLO therapy. Discontinuation of therapy has resulted in remission of AMS inside a number of days with out sequelae.
- Hemolysis: Delayed hemolytic anemia on account of enhanced purple blood cell (RBC) sequestration and acute hemolysis in keeping with intravascular hemolysis have been reported. Instances of extreme hemolysis-related renal dysfunction/failure or disseminated intravascular coagulation have occurred following infusion of IGIV. Intently monitor sufferers for scientific indicators and signs of hemolysis, notably sufferers with danger components.
- Transfusion-Associated Acute Lung Harm: Noncardiogenic pulmonary edema (transfusion-related acute lung damage [TRALI]) might happen. TRALI is characterised by extreme respiratory misery, pulmonary edema, hypoxemia, regular left ventricular perform, and fever. Sufferers with TRALI could also be managed utilizing oxygen remedy with sufficient ventilator assist. Monitor sufferers for pulmonary antagonistic reactions.
- Transmissible Infectious Brokers: As a result of ALYGLO is created from human blood, it might carry a danger of transmitting infectious brokers (eg, viruses, the variant Creutzfeldt-Jakob illness [vCJD] agent and, theoretically, the Creutzfeldt-Jakob illness [CJD] agent).
- Interference with Laboratory Checks: After infusion of immunoglobulin, the transitory rise of the varied passively transferred antibodies within the affected person’s blood might yield optimistic serological testing outcomes, with the potential for a deceptive interpretation.
- Antagonistic reactions (noticed in ≥ 5% of examine topics) had been headache, nausea/vomiting, fatigue, nasal/sinus congestion, rash, arthralgia, diarrhea, muscle ache/aches, infusion web site ache/swelling, stomach ache/discomfort, cough, and dizziness.
- It is suggested that ALYGLO be administered individually from different medicine or medicines.
Please see Vital Security Info for ALYGLO on the previous pages and seek advice from the complete Prescribing Information (PI) or go to Alyglo.com.
You probably have an inquiry associated to drug security, or to report antagonistic occasions, please contact GC Biopharma USA at 1-833-426-6426 or electronic mail [email protected]. You too can go to FDA.gov/medwatch or name 1-800-FDA-1088.
This press launch might comprise forward-looking statements that categorical the present beliefs and expectations of the administration at GC Biopharma and GC Biopharma USA. Such views don’t signify any assure by both entity or its authorities of future efficiency and contain recognized and unknown dangers, uncertainties, and different components. GC Biopharma and GC Biopharma USA undertake no obligation to replace or revise any forward-looking assertion contained on this press launch or every other forward-looking statements they could make, besides as required by legislation or inventory trade rule.
References: 1. Kang GB, Huber A, Lee J, et al. Cation trade chromatography removes FXIa from a ten% intravenous immunoglobulin preparation. Entrance Cardiovasc Med. 2023;10:1253177. 2. ALYGLO Prescribing Info. GC Biopharma; 2023.
SOURCE GC Biopharma USA Inc.
