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GC Biopharma Enhances IVIG Safety Profile with Advanced Prothrombotic Impurity Detection Technology
GC Biopharma (006280.KS), a global leader in plasma-derived protein therapies, today announced a significant advancement in the safety monitoring of intravenous immunoglobulin (IVIG). The company has developed and validated a proprietary enzyme-linked immunosorbent assay (ELISA) that effectively mitigates heterophilic antibody interference to precisely measure Factor XI (FXI) levels—a critical impurity linked to thromboembolic risks.
About this update from Gc Biopharma Corp.
[{"type":"list","items":[{"val":[{"type":"text","content":"Proprietary analytical method for precise Factor XI (FXI) measurement published in the Journal of Microbiology and Biotechnology","length":128,"tagName":"p"}]},{"val":[{"type":"text","content":"Novel IgG Blocker eliminates heterophilic antibody interference, ensuring clinical-grade purity and mitigating thromboembolic risks","length":131,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":259,"olType":false},{"type":"text","content":"YONGIN, South Korea, April 6, 2026 /PRNewswire/ -- GC Biopharma (006280.KS), a global leader in plasma-derived protein therapies, today announced a significant advancement in the safety monitoring of intravenous immunoglobulin (IVIG). The company has developed and validated a proprietary enzyme-linked immunosorbent assay (ELISA) that effectively mitigates heterophilic antibody interference to precisely measure Factor XI (FXI) levels—a critical impurity linked to thromboembolic risks.","length":488,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/GC Biopharma)","displaySize":"","headline":null,"caption":"(PRNewsfoto/GC Biopharma)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":400,"url":"https://media.zenfs.com/en/prnewswire.com/4b834899abdf3d99fcde8560d438cc9a"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/EIVf4qASxl1bc2Gp0toZYw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTcwNQ--/https://media.zenfs.com/en/prnewswire.com/4b834899abdf3d99fcde8560d438cc9a","width":400,"height":400}},"href":"https://mma.prnewswire.com/media/1888566/GC_Biopharma_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"The study, titled "Development and Validation of an Enzyme-Linked Immunosorbent Assay for Measuring Factor XI in Intravenous Immunoglobulin Products by Mitigating Heterophilic Antibody Interference," was published in the April 2026 issue of the Journal of Microbiology and Biotechnology (JMB).","length":303,"tagName":"p"},{"type":"text","content":"Thromboembolic events associated with IVIG therapy have been linked to activated coagulation factors, prompting global regulatory bodies, including the U.S. FDA, to mandate rigorous monitoring of FXI levels. However, traditional analytical methods often encounter technical limitations due to high-concentration IgG—the primary component of IVIG—interfering with...