Company joins Ministry of Trade, Industry and Energy's biohealth R&D project to advance CGT manufacturing processes
Helixmith, led by CEO Jang Song-seon, is moving to secure a next-generation "smart manufacturing process" for cell and gene therapies (CGT) by integrating AI technology, with government support.
The company announced Wednesday that it has been selected for the Ministry of Trade, Industry and Energy's first-round 2026 new biohealth R&D project.
The consortium, led by Wikioptix and including Helixmith and UX Factory as well as the Korea Institute of Machinery and Materials, will receive 4.75 billion won in government funding out of a total R&D budget of 6.54 billion won ($4.25 million). Helixmith will be responsible for technology demonstration, drawing on its in-house GMP (Good Manufacturing Practice) production infrastructure.
The project is divided into two tracks: biotech industry development and CGT manufacturing process advancement. The Helixmith consortium will carry out the second track. It aims to analyze data obtained from cell samples using AI-based, next-generation real-time cell imaging technology and apply the results to CGT manufacturing processes. The goal is to boost process speed and productivity while improving quality, reproducibility and accuracy.
The ultimate objective is to develop a "non-invasive, continuous analysis system" capable of monitoring cells in their natural state in real time without causing cellular damage. The plan calls for eliminating the cell-alteration risk associated with conventional periodic sampling and preprocessing, and using an AI engine to raise process speed and quality reproducibility to the highest possible level. The system is expected to significantly reduce error rates during production by enabling uninterrupted tracking of dynamic cellular changes throughout the culture period.
"The competitiveness of advanced biopharmaceuticals depends on data-driven, precise quality control," said Lee Jun-seop, head of research at Helixmith. "We will build a standardized manufacturing ecosystem by organically combining precision optical hardware and AI algorithms with biotechnology."
Lee added that the company intends to "complete smart manufacturing standards and accelerate global commercialization and overseas partnership expansion — momentum that has been building through Engensis' recent product approval in China and our participation in BIO USA 2026 in the United States."
Helixmith holds a range of cell and gene therapy assets, including core CAR (chimeric antigen receptor) technology. The company also has experience developing the gene therapy Engensis, and a Chinese partner recently received local product approval for a treatment based on Engensis.
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