Reducing the Risk of IVIG-Associated Aseptic Meningitis

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Abstract

Intravenous immunoglobulin (IVIG) therapy, while essential for treating autoimmune and immunodeficiency conditions, carries a rare but serious risk of aseptic meningitis (AM)—a condition characterized by inflammation of the meninges following infusion. Research suggests that protein aggregation, triggered by air bubble exposure and mechanical stress during infusion, may play a significant role in immune activation and adverse neurologic events.

This white paper explores how air-to-liquid interfaces, foaming, and handling-induced agitation contribute to protein instability in IVIG preparations. It introduces I2F , a novel, single-use device engineered to eliminate air bubbles and reduce mechanical stress during the infusion process. By replacing vented spike sets and preventing bubble intrusion, I2F helps preserve protein integrity, reduce immunogenic potential, and improve infusion consistency.

I2F offers a simple, scalable strategy for mitigating IVIG-related complications like AM, especially in high-risk patient populations. Its integration into infusion workflows may elevate safety standards, improve therapeutic efficacy, and reduce treatment-related risks in biologic drug delivery.

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