GCCL, as the central lab for the clinical development of GC Biopharma’s anthrax vaccine “BARYTHRAX(GC1109),” 

which was recently approved by the Ministry of Food and Drug Safety (MFDS), 

provided full-spectrum analytical support across the non-clinical and clinical phases, playing a pivotal role in the vaccine’s successful development.

Jointly developed by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA) in preparation for national biosecurity threats such as bioterrorism, BARYTHRAX is Korea’s 39th domestically approved new drug, receiving MFDS approval on April 8, 2025.

BARYTHRAX is the world’s first recombinant protein anthrax vaccine, created using genetic recombination technology to produce protective antigen (PA) proteins that deliver two types of anthrax toxin components into cells. This triggers an immune response via PA, effectively preventing anthrax infection. 

Throughout the vaccine’s development, GCCL provided end-to-end support—spanning bioanalytical method validation, 

sample analysis, central lab operations, and MFDS regulatory inspection readiness—ensuring analytical excellence at every step.

✅ Validated Anti-PA IgG and TNA assays across the full clinical timeline

In the non-clinical stage, GCCL successfully conducted toxin neutralization assays (TNA) for protective antigens (PA) using rabbit serum samples.
During clinical trials, ELISA-based Anti-PA IgG and TNA methods were rigorously validated following international guidelines.
These validated methods were used for precise analysis of clinical samples, providing high-quality data throughout the study.

✅ GCLP-certified central lab operations and multi-site coordination

As a fully GCLP-certified central lab, GCCL oversaw the entire lifecycle of clinical sample management, 

including collection, transport, storage, preprocessing, and analysis across multiple clinical sites in Korea.
Through systematic processes and stringent quality control, GCCL ensured data consistency and integrity,

even in the complex landscape of multi-site clinical trials—contributing significantly to the reliability and success of the vaccine’s development.

✅ Successful participation in MFDS regulatory inspection

GCCL also played a direct role in the MFDS clinical trial site inspection, successfully demonstrating the lab’s technical expertise and quality systems.
Our data and management processes served as a critical foundation for regulatory approval,

helping to bring Korea’s first anthrax vaccine to commercialization.

We are proud to have meaningfully contributed to a project of national significance from beginning to end.

This approval exemplifies how GCCL supports technological self-reliance in Korea’s vaccine development ecosystem.

With world-class infrastructure and deep expertise in infectious disease analysis, 

GCCL remains committed to leading the delivery of high-quality analytical solutions for the development of vaccines and biopharmaceuticals worldwide.