Refined Process Improves Immune Globulin Manufacturing
A new manufacturing update for immune globulin therapies could help reduce the risk of certain treatment-related complications.
Updated on Oct. 15, 2026 in Heart Disease
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ADMA Biologics has released peer-reviewed data demonstrating a manufacturing optimization for its immune globulin products. The process successfully reduced procoagulant impurities, which may provide updated quality benchmarks for patients who rely on intravenous immunoglobulin therapies.
Why it matters
Reducing procoagulant impurities in therapeutic products is critical for minimizing the risk of thromboembolic events, a known safety concern in immune globulin treatment. This research validates a refined purification process that prioritizes patient safety while maintaining the necessary potency of the therapy.
A peer-reviewed manufacturing optimization study evaluated three commercial-scale lots of immune globulin products. Results showed that procoagulant and product-related impurities were maintained at or below quantification limits, with no thromboembolic events reported during a 13-month surveillance period.
The players
ADMA Biologics
A pharmaceutical company specializing in the development and manufacturing of specialty plasma-derived biologics.
The details
The manufacturing process utilizes plasma fractionation and purification to enhance product purity. By optimizing this sequence, the manufacturer removed specific impurities linked to thrombosis risk while successfully maintaining immunoglobulin yield. Chromatographic testing confirmed the absence of immunoglobulin aggregates and fragments, ensuring the products remain stable and consistent in their liquid form.
Timeline
April 2019: FDA approval of ASCENIV.
May 2019: FDA approval of BIVIGAM.
July 1, 2025 – July 31, 2026: Postmarketing surveillance period.
October 15, 2026: Publication of the peer-reviewed article.
Health Landscape
This study aligns with the broader medical goal of optimizing the safety profiles of plasma-derived therapies to reduce treatment-related complications. It marks a shift toward more rigorous, transparent validation of manufacturing purification processes for patients with immune deficiencies.
Patients who receive immune globulin therapy should discuss any safety concerns regarding thromboembolic risks with their clinician. This information reinforces the importance of tracking and reporting adverse events during ongoing treatment to help physicians make informed care decisions.
The takeaway
Manufacturing refinements that reduce impurities are vital to improving the safety of immunoglobulin treatments. Patients should continue to monitor their health during therapy and report any new symptoms or concerns to their healthcare provider.
Further reading
For more on managing cardiovascular health, visit the Heart Disease section.
More information
View the complete peer-reviewed manufacturing optimization study.
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Do you trust that biopharmaceutical companies conduct sufficient safety testing for new manufacturing methods?
