CHA Biotech Co., Ltd. participates in government project to establish an advanced biopharmaceutical quality assessment platform

[Financial News] CHA Biotech Co., Ltd. is participating in the government-led project to establish an advanced biopharmaceutical quality assessment platform and will develop analysis technology for cell and gene therapies (CGT).
CHA Biotech Co., Ltd. announced on the 3rd that it had been selected as a joint research and development institution for the Bio-Innovation Foundation Creation project under the Bio Medical Technology Development Grant organized by the Ministry of Science and ICT.
The project aims to establish the Advanced Biopharmaceutical Quality Assessment Technology Development Platform (K-CGTAP), a public infrastructure initiative supporting domestic CGT research and development and quality assessment.
The project is led by CHA Bundang Medical Center, with joint participation from CHA Biotech Co., Ltd., the Korea Research Institute of Bioscience and Biotechnology (KRIBB), Korea University (KU), the Industry-Academic Cooperation Foundation of CHA University College of Medicine, and the Korea Testing & Research Institute (KTR). The research period runs from April 2026 to December 2030, with a total research and development budget of approximately KRW 13.7 billion. Government funding accounts for approximately KRW 12.7 billion of this amount.
Because CGTs use living cells or genetic material as therapeutic agents, their structures and mechanisms of action are more complex than those of conventional synthetic drugs. Accordingly, quality analysis technology capable of accurately verifying product identity, purity, safety, and potency is considered an important factor in clinical trials and commercialization.
Currently, Korea lacks sufficient standardized analytical methods and validation infrastructure for CGTs, so some analyses rely on specialized overseas institutions. It has also been pointed out that data continuity is difficult to ensure when moving from the research and development stage to GMP manufacturing and clinical stages because testing methods vary among research institutions and companies.
K-CGTAP aims to establish a standardized quality assessment platform that can be used from the research and development stage through GMP manufacturing and preparation for an Investigational New Drug (IND) application.
In this project, CHA Biotech Co., Ltd. will participate in the development of cell therapy analysis technology and potency testing methods. It plans to use its proprietary CGT pipeline to verify the suitability and reproducibility of the analytical technologies developed, then transfer them to a GMP manufacturing and quality control system for validation.
The validated analytical technologies will be linked to the chemistry, manufacturing, and controls (CMC) data and quality assessment data required for IND applications. In cooperation with its U.S. subsidiary, Matica Biotechnology, the company plans to verify whether standard test methods developed in Korea can also be applied at U.S. manufacturing sites and establish the analytical and quality control foundation needed for U.S. Food and Drug Administration (FDA) IND applications.
CHA Biotech Co., Ltd. was recently selected for the K-HERO Nurturing and Support Project and is pursuing the development of a CGT pipeline based on the CHAMS-CHAGE platform.
Nam Soo-yeon, CHA Biotech Co., Ltd.'s head of R&D, said, "Based on our accumulated research and development and GMP capabilities, we will contribute to the establishment of K-CGTAP, reduce domestic companies' dependence on overseas analysis, and lay the foundation for the global use of domestic quality assessment technology."

[email protected] Jeong Sang-hee Reporter