GC Biopharma announced on Friday that its U.S. subsidiary, GC Biopharma USA, will present research findings on the aggregation characteristics of intravenous immunoglobulin (IVIG) formulations at the annual conference of the National Home Infusion Association (NHIA 2026).
The conference is scheduled to take place from April 18 to 22 in Denver, Colorado.
The study’s primary focus was to evaluate the degree of protein aggregation in commercially available immunoglobulin products by comparing protein size and particle shape.
Immunoglobulin, a widely used treatment for immune disorders, has seen an expansion in its applications. This growth has heightened the importance of product quality and safety.
Protein aggregation, in particular, can significantly impact drug stability and patient reactions during administration. As a result, effective management of this process during manufacturing has become a critical quality factor.
The research compared five 10% immunoglobulin products, including GC Biopharma’s Alyglo. Analysis revealed that Alyglo demonstrated a significantly lower ratio of protein aggregates and fragments compared to competing products.
Conversely, the ratios of monomers and dimers, which perform normal immune functions in the body, remained relatively high in Alyglo, confirming the product’s stability. These findings suggest that Alyglo’s manufacturing process effectively reduces protein aggregation, potentially allowing for safer patient administration. The company believes this research will enhance understanding of formulation quality characteristics and serve as a valuable reference for product selection.
A spokesperson for GC Biopharma stated that its advanced purification processes, based on over 50 years of accumulated manufacturing technology for plasma-derived products, minimize impurities and protein aggregation. It remains committed to providing safer and more reliable treatment options for patients.