ADMA Biologics Study Shows Optimized IVIG Process Removes Impurities Linked to Thrombosis Risk
Bitget2026/10/15 11:05- ADMA Biologics announced publication of peer-reviewed findings on its optimized intravenous immune globulin manufacturing process in Frontiers in Cardiovascular Medicine.
- Testing of three commercial-scale lots showed effective removal of impurities linked to thrombosis risk while preserving immunoglobulin quality.
- The FDA-licensed optimized process increased immunoglobulin yield without compromising product integrity.
- No thromboembolic events were reported for products manufactured using the process during surveillance from July 1, 2025, through July 31, 2026.
- Limited testing and potential underreporting prevent conclusions that risk is absent; thrombosis remains a labeled risk for ASCENIV and BIVIGAM.
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