GC Biopharma Presents New Data at CIS 2026 to Expand Analytical Understanding of IVIG Product Characteristics
GC Biopharma USA, Inc., a leader in plasma-derived products, announced 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
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.
Source link: https://www.businesswire.com/
