Helixmith Obtains License for Management of Human Cells and Others

[Asia Economy Reporter Lee Gwan-joo] Helixmith announced on the 30th that it has obtained the 'Human Cell Management Business License' from the Ministry of Food and Drug Safety.

The human cell management business license was newly established alongside the enforcement of the Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals, and is necessary for collecting, processing, and supplying human cells that serve as raw materials for advanced biopharmaceuticals.

Helixmith's CGT Center has fulfilled all the necessary procedures for the contract development and manufacturing organization (CDMO) business by acquiring this license following the advanced biopharmaceutical manufacturing license.

The CGT Center is a cell and gene therapy GMP production facility completed in September last year at the Seoul Magok headquarters, established with a focus on providing high-quality clinical samples. It is equipped with infrastructure that offers integrated solutions across all areas including manufacturing, process development, analytical technology development, and storage and supply of cell and gene therapies, enabling companies to enter clinical trials.

Baek Kyung-dong, Executive Director of Helixmith, who oversees process development and production headquarters, said, "Obtaining the human cell management business license is evidence that our CDMO business is progressing as planned and that the GMP system for producing high-quality pharmaceuticals has been successfully established. Based on Helixmith's long-standing technology, accumulated know-how, and assets, we will achieve visible results in the CDMO market."