#USA #GC Biopharma #Teaneck #ALYGLO #IVIG Products

GC Biopharma's Presentation at ISTH 2025

GC Biopharma USA, Inc., an established leader in plasma-derived therapies, made significant strides at the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress. They showcased new findings on the viscosity levels of various commercially available 10% intravenous immunoglobulin (IVIG) products, paving the way for improved understanding and safety in treatment protocols.

Understanding the Importance of Viscosity

Viscosity is a critical factor when considering the safety of IVIG infusions. High viscosity is a known risk factor associated with thromboembolic events (TEEs), which can complicate treatment for vulnerable patients. As it stands, IVIG infusions can elevate plasma viscosity both acutely and cumulatively, leading to heightened risks for certain patient populations.

During the conference, GC Biopharma presented data revealing that the viscosity of five commercially available IVIG products was evaluated at temperatures ranging from 4°C to 25°C. The results indicated a consistent decrease in viscosity with rising temperatures, suggesting that infusions at room temperature (25°C) may help reduce related risks. This revelation could shift existing IVIG administration practices, enhancing patient safety.

Methodology of the Study

The study utilized standardized methodologies for measuring viscosity, which allowed for a normalized evaluation across the different products. These approaches underline the importance of analyzing the chemical and physical properties of IVIG therapies, such as viscosity and purity, as important parameters for assessing safety, especially for patients with a higher thrombotic risk.

Expert Insights

The data was presented by Suzanne Strasters, MSN, FNP-C, the Head of Clinical Education at GC Biopharma USA. Strasters expressed the need for further investigation, stating, "These preliminary results warrant further investigation to determine whether there are differences in viscosities between products, which may have important clinical implications for product selection in at-risk patients."

The poster session entitled, "Investigation into the Viscosity of Commercial IG Preparations," included detailed analyses of products such as ALYGLO®, OCTAGAM®, GAMUNEX®-C, PRIVIGEN®, and GAMMAGARD LIQUID®.

ALYGLO®: A Focused Approach

Among the products highlighted, ALYGLO® stands out as a significant FDA-approved intravenous immunoglobulin therapy for treating primary humoral immunodeficiency (PI) in adults aged 17 and older. This product is part of GC Biopharma's rich legacy in plasma product manufacturing, boasting a distribution network that spans over 50 countries.

ALYGLO® employs stringent manufacturing processes designed to mitigate virus transmission risks, including advanced solvent/detergent treatment and nanofiltration techniques. It leverages G-XI™ Technology, a novel cation exchange chromatography method, effectively removing FXIa to undetectable levels, thus further enhancing patient safety.

Conclusion

As GC Biopharma moves forward post-ISTH 2025, the insights gleaned from this research stand to revolutionize IVIG administration practices. The findings advocate for a more informed approach regarding the selection of IVIG products, especially for patients identified as being at higher risk for thromboembolic events. This aligns with GC Biopharma's mission to provide safe, effective, and quality healthcare solutions, reflecting their position as a beacon of progress in the biopharmaceutical industry.

For further details about the products discussed, particularly ALYGLO and G-XI™ Technology, interested parties are encouraged to visit GC Biopharma's official websites or GC Biopharma USA.