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GC Biopharma hosts symposium at the IGNS National Conference: ALYGLO® (IMMUNE GLOBULIN INTRAVENOUS, HUMAN-STWK), 10%: Advancing the IVIG manufacturing process with Cation Exchange (CEX) Chromatography
Teaneck, NJ/PRNewswire - GC Biopharma hosted a 60-minute symposium at the IgNS National Conference in Washington, DC on Saturday, October 19. The symposium, titled ALYGLO® (immune globulin intravenous, human-stwk), 10%: Advancing the IVIG Manufacturing Process With Cation Exchange (CEX) Chromatography, provided an overview of ALYGLO’s entry into the US market, covering its indication and data on safety and efficacy. The intent of the session was to provide essential knowledge to help incorporate ALYGLO into clinical practice, providing guidance for practical aspects of product selection, and best practices for administration.
Participants also learned about cation exchange (CEX) chromatography, the extra step in ALYGLO’s manufacturing process with demonstrated ability to reduce coagulation factor XIa (FXIa) to undetectable limits. FXIa is a plasma-based enzyme that has been linked to IVIG-related thromboembolic events. It has been a longstanding goal within the immunoglobulin (Ig) community to remove FXIa in manufacturing.1
The session was hosted by a panel of seasoned experts who each bring a unique perspective.
- Dr. Stacey Ness is a Medical Science Liaison on the Medical Affairs team at GC Biopharma USA. She brings to us significant experience with specialty pharmacies and the clinical management of chronic diseases and has special interest in working with patient advocacy and support groups.
- Suzanne Strasters, MSN, FNP-C, IgCN is a Nurse Practitioner with extensive experience with clinical nursing, specializing in Ig infusion therapies and providing clinical education to nurses, clinical staff, and patients on various Ig therapies. Currently, Suzanne is the Head of Clinical Education at GC Biopharma USA.
- Ryan Dorfman, PhD is a seasoned expert in pharmaceutical product development, analytical method development, and the manufacturing of reagents and custom collection devices. His vast technical expertise spans multiple disciplines, including protein biochemistry, enzymology, and blood coagulation.
The symposium was open to any attendees involved in the administration and management of Ig therapy, including clinicians (nurses, pharmacists, and physicians) alongside business leaders from the immunoglobulin (Ig) therapy and biologics industry including C-suite executives, sales and marketing teams, pharmacy owners, market access professionals, and managed care decision-makers.
This event reflected GC Biopharma’s approach to building relationships within the communities they serve through support and transparent conversation.
About ALYGLO®
ALYGLO is a liquid solution containing 10% immunoglobulin G (100 mg/mL) for intravenous infusion, manufactured from pooled human plasma from US donors. The manufacturing process includes three steps to reduce the risk of virus transmission. These include fractionation, solvent/detergent treatment, and nanofiltration. ALYGLO also uses its novel Cation Exchange Chromatography (CEX) in the manufacturing process for removing FXIa to undetectable levels.
About GC Biopharma Corp.
GC Biopharma Corp (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving 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, 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 will further extend its footprint, bringing its expertise and legacy to the US.
Please see Important Safety Information for ALYGLO on the following 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.
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
- 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.
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.
Reference: 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; 2023.
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ALY-C-0080 12/2024
