ADMA Biologics Details Optimized IVIG Manufacturing
A new peer-reviewed study outlines process improvements that effectively reduce procoagulant impurities in intravenous immune globulins.
Updated on Oct. 15, 2026 in Heart Disease
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ADMA Biologics has released peer-reviewed data demonstrating the efficacy of its optimized manufacturing process for intravenous immune globulin (IVIG) products. The study confirms that the refined method removes procoagulant impurities while maintaining high immunoglobulin purity and yield.
Why it matters
The optimization aims to bolster safety profiles by minimizing thrombotic risks associated with impurities, addressing a critical concern for long-term patient health. These process refinements ensure that therapeutic products remain pure and reliable for clinical use.
A study of three commercial-scale lots showed that procoagulant and product-related impurities were consistently at or below quantification limits. The lots also maintained an average non-activated partial thromboplastin time of over 250 seconds.
The players
ADMA Biologics
A biopharmaceutical company based in Ramsey, New Jersey, that specializes in the development and manufacturing of specialty plasma-derived biologics.
The details
The study, published in Frontiers in Cardiovascular Medicine, utilized chromatographic testing to confirm the absence of immunoglobulin aggregates or fragments. Researchers validated that the improved plasma fractionation and purification facility in Boca Raton successfully eliminates potential triggers for thromboembolic events.
Timeline
July 1, 2025 – July 31, 2026: Evaluation period for postmarketing surveillance regarding thromboembolic events.
April 2019: FDA approval of ASCENIV.
May 2019: FDA approval of BIVIGAM.
October 15, 2026: Publication date of the peer-reviewed study in Frontiers in Cardiovascular Medicine.
The Big Picture
This study follows the standard for transparent reporting of pharmaceutical manufacturing processes within Frontiers in Cardiovascular Medicine. It demonstrates how industry data undergoes rigorous, independent scientific review to ensure patient safety standards are met.
These manufacturing enhancements provide patients with assurance that IVIG treatments like ASCENIV and BIVIGAM maintain high purity standards with reduced risk of impurities. Patients can benefit from products engineered to minimize adverse thrombotic events.
The takeaway
Maintaining strict purity levels in plasma-derived products is vital for reducing risks in long-term immune therapy. This research highlights the efficacy of modern chromatography in successfully identifying and removing harmful impurities.
Further reading
For broader context on current clinical advancements, visit the Heart Disease section.
More information
Review the full details of the peer-reviewed manufacturing optimization study for complete technical methodology.
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Do you trust that biopharmaceutical companies conduct sufficient safety testing for new manufacturing methods?
