GC Green Cross US Subsidiary to Present IVIG Aggregation Study Results at NHIA 2026
GC Green Cross announced on April 17 that its U.S. subsidiary, GC Biopharma USA, will present research results evaluating the aggregation characteristics of intravenous immunoglobulin (IVIG) formulations at the annual conference of the National Home Infusion Association (NHIA 2026). The conference will be held in Denver, Colorado, United States, from April 18 to 22, local time.
The key focus of this study is the evaluation of aggregation levels by comparing the protein size and particle morphology of commercially available immunoglobulin formulations. Immunoglobulins are widely used therapeutics for treating immune disorders, and as their applications expand, interest in their quality and safety is also increasing. Protein aggregation, where proteins clump together, is a critical quality factor in manufacturing because it can affect drug stability and cause adverse reactions during patient administration.
The research compared five different 10% immunoglobulin products, including GC Green Cross’s Aliglo (ALYGLO®). The analysis found that Aliglo showed significantly lower levels of protein aggregates (polymers) and fragments compared to competing products. In contrast, the proportions of monomers and dimers, which perform normal immune functions in vivo, were relatively higher, confirming the stability of the product, according to the company.
This outcome is attributed to Aliglo’s manufacturing process, which effectively reduces protein aggregation, suggesting that the product may offer safer administration for patients. The company expects this research to enhance understanding of formulation quality characteristics and to serve as reference material for product selection.
A GC Green Cross representative stated, "Based on more than 50 years of accumulated expertise in plasma fractionation manufacturing, we apply advanced purification processes that minimize impurities and protein aggregation."
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Meanwhile, this study, titled "Evaluation of Aggregation Characteristics of Commercial Intravenous Immunoglobulin Products," is scheduled to be presented at the NHIA 2026 exhibition hall on April 20 from 1:00 p.m. to 2:30 p.m.
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