GC Biopharma has developed and validated a proprietary enzyme-linked immunosorbent assay (ELISA) to lessen an impurity linked to thromboembolic risks.

The ELISA effectively mitigates heterophilic antibody interference in order to precisely measure levels of the critical impurity Factor XI (FXI). GC Biopharma characterizes the assay’s validation as a significant step forward in safety monitoring of intravenous immunoglobulin (IVIG).

Significance of Thromboembolic Events

IVIG therapy may prompt associated thromboembolic events linked to activated coagulation factors. In response, global regulatory bodies including the U.S. FDA have ordered rigorous monitoring of FXI levels.

GC Biopharma’s R&D team, experienced in plasma-derived protein therapies, employed a selective immunoglobulin G (IgG) blocker in this enhanced assay. The company said this approach lessens non-specific protein reactions, to allow for isolated, precise FXI measurement regardless of IgG concentration.

How GC Biopharma Innovates

According to GC Biopharma, high concentration IgG, which is the primary component of IVIG, exposes technical limitations in traditional analytical methods. GC Biopharma’s proprietary ELISA works to minimize resulting detection signal interference that results in false positive readings or impurity detection difficulties. If not corrected, these problems can impact accurate quality control in the manufacturing process.

GC Biopharma’s platform has been fully validated according to International Council for Harmonisation Q2(R2) guidelines.

A Proprietary Platform

Jae Uk Jeong, Head of R&D for GC Biopharma (formerly Green Cross Corporation), said the validation is a step forward.

“By establishing this advanced analytical framework, we have significantly elevated our quality control capabilities for immunoglobulin therapies,” Jeong said. “We remain committed to leveraging validated, precision-driven technologies to supply high-quality plasma derivatives to the global market.”

A related study, “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.