CHA Biotech to Address Bottlenecks in CGT Commercialization as Key Participant in National Quality Assessment Platform

[Financial News] CHA Biotech is accelerating efforts to secure the quality assessment and analytical technologies needed to commercialize cell and gene therapies (CGTs). By participating in the construction of a national CGT analysis platform backed by approximately KRW 12.7 billion in government support, the company will validate the technologies through its own pipelines and connect them to its U.S. manufacturing subsidiary to establish a foundation for responding to global regulations.
According to the bioindustry on the 3rd, CHA Biotech was selected as a joint research and development institution for the Ministry of Science and ICT’s Bio and Medical Technology Development Program. The project involves establishing the Advanced Biopharmaceutical Quality Assessment Technology Development Platform, known as K-CGTAP. Bundang CHA Hospital is leading the project, which will receive a total investment of KRW 13.7 billion through the end of 2030.
The project’s core objective is to reduce the “analytical bottleneck” faced by domestic CGT companies as they enter clinical trials. Because CGTs use cells and genetic material, companies must demonstrate identity, purity, safety, and potency—the measure used to assess actual therapeutic efficacy—according to consistent standards. A lack of standardized infrastructure in Korea has led companies to rely on overseas institutions for some analyses. Differences between testing methods used in research and those used during GMP manufacturing have also weakened data continuity.
Drawing on its experience developing stem cell, immune cell, and genetically modified cell therapies, CHA Biotech will participate in developing analytical technologies and potency assays. In particular, it will use its own CGT pipelines to verify the technologies’ suitability and reproducibility before transferring them to GMP manufacturing and quality-control systems. Ultimately, the company plans to link the results to the chemistry, manufacturing, and controls (CMC) data required for an investigational new drug (IND) application.
Collaboration with its U.S. subsidiary, Matica Biotechnology, is another distinguishing feature. CHA Biotech will apply the standardized testing methods established in Korea at a U.S. manufacturing site to assess their applicability to responses for Food and Drug Administration (FDA) IND submissions. The structure goes beyond developing analytical technologies; it is designed to extend Korea’s quality assessment system through the global regulatory approval stage.
Synergies are also expected with the recently selected K-HERO Development and Support Program. Through K-HERO, the company will accelerate development of CGT pipelines based on the CHAMS-CHAGE platform, while strengthening its analytical and quality assessment capabilities through K-CGTAP. In this way, it aims to establish a commercialization system spanning candidate development, quality assessment, GMP manufacturing, and IND submission.
A bioindustry official said, “For CGTs, the speed of clinical entry depends not only on the competitiveness of the candidate but also on how consistently its quality can be demonstrated. Companies with their own pipelines, GMP capabilities, and U.S. manufacturing bases are relatively well positioned to connect analytical technologies to actual commercialization.”
Nam Su-yeon, CHA Biotech’s head of R&D, emphasized, “We will reduce domestic companies’ reliance on overseas analysis and establish a foundation that enables Korean quality assessment technologies to be used in global regulatory environments.”


[email protected] Kim Kyung-a Reporter