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Pharmaceutical R&D

GC Green Cross Unveils U.S. Study Reaffirming Aliglo Quality

Dong-A Ilbo | Updated 2026.04.17
GC Biopharma USA to Present at U.S. National Home Infusion Association Conference
Comparative Analysis of Protein Aggregation, the Key to Immunoglobulin Stability
Expanding the Applications of Immunoglobulin… Spotlight on Quality and Safety
Study Shows Reduced Protein Aggregation Versus Competing Products
 
GC Pharma (GC Green Cross) announced on the 17th that its U.S. subsidiary, GC Biopharma USA, will present research results evaluating the aggregation profile of intravenous immunoglobulin (IVIG) products at the National Home Infusion Association (NHIA 2026) Annual Conference & Expo in the United States. The conference is scheduled to be held in Denver, Colorado, from April 18 to 22 (local time).

Specifically, under the title “Assessment of the Aggregation Profile of Commercially Available Intravenous Immunoglobulin Products,” the study’s findings are to be presented on April 20 from 1:00 p.m. to 2:30 p.m. on the exhibition floor at NHIA 2026.

According to GC Pharma, the core of this study was to evaluate the degree of protein aggregation within products by comparing protein size and particle morphology in marketed immunoglobulin preparations. Immunoglobulin is a pharmaceutical product widely used in the treatment of immune disorders. As its range of applications has expanded in recent years, the importance of product quality and safety has drawn increasing attention. It is also cited as a next-generation growth driver for GC Pharma.

In particular, protein “aggregation,” in which proteins clump together, is regarded as an important quality factor because it can affect drug stability and adverse reactions during administration to patients, making manufacturing know-how critical.
GC Pharma’s immunoglobulin product ‘ALYGLO’. Courtesy of GC Pharma
In the study, a total of five 10% immunoglobulin products, including GC Pharma’s immunoglobulin preparation “ALYGLO,” were compared and analyzed. As a result, ALYGLO was found to have significantly lower ratios of protein aggregates (polymers) and fragments than competing products.

Conversely, the ratios of monomers and dimers, which perform normal immune functions in vivo, were relatively high, confirming excellent product stability, according to GC Pharma.

This can be seen as the result of effectively reducing protein aggregation during the ALYGLO manufacturing process. It is being evaluated as demonstrating that safer administration to patients is possible. GC Pharma expects that this study will enhance understanding of product quality attributes and serve as supporting data when selecting products.

A GC Pharma representative stated, “Based on more than 50 years of accumulated experience in plasma fractionation manufacturing, GC Pharma applies advanced purification processes that minimize impurities and protein aggregation,” adding, “We will continue to do our utmost to provide safer and more reliable treatment options for patients.”

Kim Min-beom

AI-translated with ChatGPT. Provided as is; original Korean text prevails.
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