ADMA Biologics Announces Peer-Reviewed Publication Highlighting New Data From Its Optimized, Proprietary IVIG Manufacturing Process
Key Highlights
- ➤Optimized process removed measured procoagulant impurities across three commercial-scale IVIG lots
- ➤Average NAPTT exceeded 250 seconds, indicating very low procoagulant activity
- ➤Optimized process increased immunoglobulin yield while maintaining product quality and IgG integrity
- ➤No thromboembolic events reported from July 1, 2025 through July 31, 2026
- ➤Factor XIa levels fell below quantification limits in two of three lots
Expert Statements
Adam Grossman, President and Chief Executive Officer of ADMA Biologics
“Patients with primary humoral immunodeficiency may require lifelong immune globulin therapy, making product quality and continued manufacturing innovation critically important”
Adam Grossman, President and Chief Executive Officer of ADMA Biologics
“The findings reported in this peer-reviewed publication demonstrate the capabilities of ADMA’s proprietary manufacturing platform to remove impurities associated with thrombotic risk while maintaining immunoglobulin quality and increasing IgG recovery”
Adam Grossman, President and Chief Executive Officer of ADMA Biologics
“We believe these results further support the differentiated quality profile of our IVIG portfolio and reinforce ADMA’s commitment to advancing manufacturing science for the benefit of immune-compromised patients”
Maeve O’Connor, Chief Medical Officer, Consortium of Independent Immunology Clinics (CIIC) & CEO and Medical Director, Integrative Allergy and Immunology Care
“Thromboembolic events are uncommon but clinically important complications of immunoglobulin therapy, making the control of procoagulant impurities an important component of IVIG manufacturing”
Maeve O’Connor, Chief Medical Officer, Consortium of Independent Immunology Clinics (CIIC) & CEO and Medical Director, Integrative Allergy and Immunology Care
“The very low procoagulant activity observed in this analysis, together with effective removal of Factor XIa and other impurities and the absence of reported thromboembolic events during the post-marketing observation period, provides reassuring evidence regarding the quality and safety profile of IVIG produced using ADMA’s further optimized manufacturing process”
Optimized Process Demonstrated Effective Removal of Procoagulant Impurities While Maintaining Immunoglobulin Quality and Increasing IgG Yield
No Thromboembolic Events Were Reported for ADMA IVIG Products Manufactured Using the Optimized Process During the Postmarketing Surveillance Period Evaluated
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