GC Biopharma has developed a new analytical method to identify impurities that could potentially cause blood clots during the production of intravenous immunoglobulin (IVIG), the company announced on Monday.
The research focuses on accurately detecting trace amounts of Factor XI (FXI), a protein crucial in blood coagulation. If present in significant quantities within immunoglobulin, FXI can transform into activated FXI (FXIa) in the body, potentially triggering thromboembolism – a dangerous condition where blood clots form in blood vessels. In response, global regulatory bodies, including the U.S. Food and Drug Administration (FDA), have strongly advocated for rigorous monitoring of FXI and FXIa levels.
Previous analytical techniques were hampered by the high concentration of IgG, the primary component of immunoglobulin, which interfered with analysis signals. This interference often led to false positives or failures to detect trace impurities, compromising accuracy.
To overcome these challenges, GC Biopharma engineered an improved analytical method incorporating an IgG blocker. This innovative approach selectively suppresses non-specific reactions that interfere with the analysis, enabling precise identification of FXI, the compound responsible for blood clots.
GC Biopharma reports that they have validated this new analytical method in accordance with International Council for Harmonisation (ICH) guidelines. The company has successfully established a proprietary monitoring system capable of tracking impurities throughout the entire production process, from raw materials to finished products.
Jae-wook Jeong, head of research and development (R&D) at GC Biopharma, stated that this new analytical method significantly enhances the quality control capabilities for immunoglobulin production. Leveraging this validated precision analysis technology, it is committed to consistently supplying high-quality plasma-derived products to the global market.
The research findings have been published in the latest issue of the SCIE-indexed journal, Journal of Microbiology and Biotechnology.