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GC Biopharma's ALYGLO Stability Study: Key Findings

GC Biopharma USA, a prominent figure in the field of plasma-derived medical products, recently made headlines with the publication of a pivotal study in the Infusion Journal. The study reveals critical insights about ALYGLO®, a product designed for intravenous immunoglobulin therapy, showcasing its stability when pooled and stored under refrigerated conditions. This significant finding underscores the potential improvements in the administration of immunotherapy for patients suffering from various immune deficiencies.

The Study's Core Findings

Conducted under strict parameters, the study demonstrated that pooled samples of ALYGLO® remain within the FDA-approved release specifications for an impressive duration of up to 14 days when stored between 2-8°C (36-46°F). Notably, this was validated across three different types of flexible containers—namely polyolefin, EVA 2-port, and 3-in-1 EVA mixing containers. The parameters tested included pH levels, osmolality, molecular size distribution, total protein composition, anti-complement activity, and sterility, among others.

Dr. Stacey Ness, PharmD, who served as the lead author, emphasized the importance of these findings in aligning with real-world clinical practices. She noted, "These data support the use of pooled ALYGLO in a manner that reflects real-world infusion practice, providing meaningful insights for infusion nurses and pharmacists when making informed decisions regarding product dispensing and administration."

Presentation of Findings

To further disseminate this crucial information, Dr. Ness is set to present a poster detailing this study at the upcoming 2025 National Association of Specialty Pharmacy (NASP) Annual Meeting & Expo in Denver, Colorado, from September 14-17. The poster, titled "Stability of Immune Globulin Intravenous, Human-stwk, 10% Liquid Following Pooling and Storage in Flexible Containers," will allow attendees to delve deeper into the results of the research and their implications.

About ALYGLO®

ALYGLO® is an FDA-approved treatment specifically designed for adults aged 17 and older suffering from primary humoral immunodeficiency (PI), including conditions like congenital agammaglobulinemia and common variable immunodeficiency (CVID). The formulation is pivotal in improving patient comfort during infusion, allowing for greater mobility. The product is manufactured using advanced processes that significantly reduce the risk of virus transmission, such as solvent/detergent treatment and nanofiltration processes.

The significance of ALYGLO® in the therapeutic landscape is exemplified by GC Biopharma’s five-decade legacy in developing and distributing plasma-derived therapies internationally.

Looking Forward

As GC Biopharma continues to pave the way in plasma product innovations, the release of this study serves as a testament to their commitment to improving patient care and outcomes. The findings not only validate the effectiveness of their product but also provide healthcare professionals with the necessary data to enhance treatment methodologies.

For more detailed information regarding ALYGLO and their proprietary G-XI™ Technology, interested parties can visit GC Biopharma's website or GC Biopharma USA. As the field of immunotherapy progresses, studies like this will undoubtedly play a crucial role in shaping future therapies and patient experiences.