New Assay to Accurately Measure FXI Levels During IVIG Therapy
- By BSTQ Staff
GC Biopharma has developed a proprietary enzyme-linked immunoassay (ELISA) that effectively mitigates heterophilic antibody interference to precisely measure factor XI (FXI) levels — a critical impurity to thromboembolic risks — which will significantly advance monitoring the safety of intravenous immune globulin (IVIG).
With IVIG therapy, thromboembolic side effects have been linked to activated coagulation factors, pushing global regulatory bodies, including the U.S. FDA, to require rigorous monitoring of FXI levels. Traditional methods would often result in “false-positive” or inconclusive results due to the high-concentration IgG that would affect accurate quality control during manufacturing.
To address this, GC Biopharma created the enhanced assay incorporating a selective IgG blocker that subdues non-specific protein reactions. Even though there is a high concentration of IgG, this still allows them to find the isolated and precise measurement of FXI. This development has been fully validated in accordance with theICH Q2(R2) guidelines.
“By establishing this advanced analytical framework, we have significantly elevated our quality control capabilities for immunoglobulin therapies,” Jae Uk Jeong, head of research and development 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.”