GC Biopharma Presents IVIG Aggregation Data at NHIA 2026

Research highlights molecular size and particle characteristics across commercial IVIG products

Apr. 17, 2026 at 6:23am

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A ghostly, translucent X-ray photograph revealing the internal molecular structure and particle characteristics of an IVIG vial as glowing, ethereal lines against a dark background, conceptually illustrating the analytical research on IVIG aggregation profiles.Analytical insights into the molecular properties of IVIG products may help advance safe and effective immunoglobulin therapy as global demand rises.Denver Today

GC Biopharma, a leading plasma-derived product manufacturer, announced new research evaluating the aggregation profiles, including molecular size distribution and particle size, in commercially available intravenous immunoglobulin (IVIG) products. The data will be presented at the 2026 National Home Infusion Association (NHIA) Annual Conference in Denver.

Why it matters

Protein aggregates in IVIG preparations can influence immunogenicity, stability, and infusion tolerability, underscoring the importance of controlling impurities and aggregation during IVIG manufacturing as global demand for these therapies continues to grow.

The details

The analysis showed that GC Biopharma's ALYGLO® IVIG product had an aggregation profile with a high percentage of monomers and dimers compared to low amounts of polymers and fragments, which may help inform product selection strategies aimed at reducing immunogenicity associated with protein aggregates.

  • The poster presentation will take place on Monday, April 20, 2026, from 1:00 p.m. to 2:30 p.m. at the NHIA Expo Hall.

The players

GC Biopharma USA

A leader in plasma-derived products and the US operations and distribution company of GC Biopharma, a biopharmaceutical company delivering lifesaving and life-sustaining protein therapeutics and vaccines for over 50 years.

ALYGLO®

A glycine-stabilized 10% immunoglobulin G (100 mg/mL) for intravenous infusion, manufactured from pooled human plasma and produced using an enhanced purification process to support control of plasma-derived impurities and protein aggregation.

Alan Huber, PharmD

Director of Medical Affairs at GC Biopharma USA.

Stacey Ness, PharmD, IgCP, CSP, MSCS, AAHIVP

Medical Science Liaison, Medical Affairs at GC Biopharma USA.

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What they’re saying

“Immunoglobulin therapy is the gold standard for the treatment of primary immunodeficiency and other immune-mediated conditions. As demand for immunoglobulin therapy continues to grow with improved disease recognition, analytical characterization of IVIG preparations helps advance scientific understanding of the molecular properties of these therapies.”

— Alan Huber, Director of Medical Affairs at GC Biopharma USA

“These findings add to the ongoing characterization of IVIG preparations and provide additional analytical information on molecular size distribution and particle characteristics that may be relevant to IVIG preparation and administration. As more patients receive IVIG therapy in home settings, GC Biopharma values the opportunity to engage with home infusion providers on the latest research and advances that support safe administration and high-quality patient care.”

— Stacey Ness, Medical Science Liaison, Medical Affairs at GC Biopharma USA

What’s next

The judge in the case will decide on Tuesday whether or not to allow Walker Reed Quinn out on bail.

The takeaway

This research highlights the importance of monitoring and controlling protein aggregation in IVIG products to support safe and effective immunoglobulin therapy as global demand continues to grow.