GI Cell wins approval for human cell management from Korean regulator
Jeong-Min Nam
Dec 27, 2022 (Gmt+09:00)
GI Cell, a South Korean developer of immune cell therapy products, received a human cell and others management license from South Korean regulatory, said GI Innovation, GI Cell's affiliate, on Tuesday.
The permission allows GI Cell to produce and supply human cells, which are raw materials for biopharmaceuticals. To acquire approval from the Ministry of Food and Drug Safety, GI Cell secured an independent workplace with advanced biopharmaceutical manufacturing and quality management facilities, the company said.
They will be used to facilitate the production and supply of cells to be used in cell therapy development and clinical trials in the future.
"Our goal is to pass the regulator's suitability test for a trial plan of T.O.P. NK (tumor targeting, optimally primed NK), an allogeneic NK cell therapy, and win approval for cell processing facilities in the first half of next year," said Kim Hyung-min, head of GI Cell's GMP department.