GC Biopharma Study Confirms Stability of ALYGLO® IVIG After Pooling

GC Biopharma USA has reported new data showing that pooled ALYGLO® (immune globulin intravenous, human-stwk, 10% liquid) remains within U.S. FDA-approved release specifications for up to 14 days when refrigerated (2–8°C) in three types of flexible containers: polyolefin, EVA 2-port, and 3-in-1 EVA mixing containers.

Pooling IVIG is a routine practice aimed at streamlining administration and improving patient comfort during infusion. The in vitro study assessed pH, osmolality, protein composition, molecular size distribution, anti-complement activity, hepatitis B antibody titer, particulate matter, sterility, and other quality parameters, with all remaining within specification throughout the test period.

The findings will also be presented as a poster at the 2025 National Association of Specialty Pharmacy Annual Meeting & Expo in Denver, Colorado.

ALYGLO® is FDA-approved for treating primary humoral immunodeficiency in adults aged 17 and older and is manufactured from U.S.-sourced human plasma using multiple viral inactivation steps, including solvent/detergent treatment and nanofiltration.

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