GC Biopharma reveals a major enhancement in the field of safety monitoring for intravenous immunoglobulin (IVIG). Their proprietary enzyme-linked immunosorbent assay (ELISA) was developed and validated to effectively determine Factor XI (FXI), which is the main component contributing to thromboembolic risks. Indeed, the detection of even minute amounts of impurities in IVIG products has been a major difficulty for years. The high levels of immunoglobulin G (IgG) in these products usually hinder the traditional test methods.
In a paper published by the Journal of Microbiology and Biotechnology (JMB), April 2026 issue, it was pointed out that heterophilic antibody interference, a kind of interference caused by the antibodies of different species, can yield false results such as false positives or missed detections while using traditional assays. To address this problem, GC Biopharma resorted to a new method that uses a selective IgG Blocker. This selective blocker of IgG reduces the non-specific protein interactions so it is possible to accurately measure FXI even with different levels of IgG.
This new set-up, in which the innovative assay is central, has undergone a full validation process in compliance with the ICH Q2(R2) guidelines. This further enhances the trust that the industry has in the assay for quality control of plasma-derived therapies. Besides that, the improved accuracy in detecting the impurity not only helps with better fulfilling the global regulatory requirements such as those by the U. S. FDA but also results in better protection of patients who are administered IVIG treatments.
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“By establishing this advanced analytical framework, we have significantly elevated our quality control capabilities for immunoglobulin therapies,” said Jae Uk Jeong, Head of R&D at GC Biopharma. “We remain committed to leveraging validated, precision-driven technologies to supply high-quality plasma derivatives to the global market, prioritizing patient safety and clinical excellence above all.”
