ADMA Biologics study shows optimized IVIG process removes impurities linked to thrombosis risk
ADMA•ADMA Biologics said peer-reviewed findings showed its optimized IVIG manufacturing process removed impurities linked to thrombosis risk while preserving immunoglobulin quality. No thromboembolic events were reported for products made using the process during surveillance from July 1, 2025, through July 31, 2026, but the company noted limitations that prevent concluding the risk is absent.
1. Study findings
Testing of three commercial-scale lots showed effective removal of impurities linked to thrombosis risk while preserving immunoglobulin quality. The FDA-licensed 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 the risk is absent, and thrombosis remains a labeled risk for ASCENIV and BIVIGAM.
