Obtains License to Manage Human Cells
GC Cell, a company specializing in cell therapy, announced on March 2 that it has obtained a license to manage human cells for the first time among high-tech biopharmaceutical manufacturers in Korea.
The license on human cell management was newly introduced by the Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals. A company needs to have the license in order to collect, process, and supply human cells, which are raw materials for high-tech biopharmaceuticals.
In the case of cell therapeutics, the raw material is extracted from the human body, human cells or tissues. So a contract manufacturing organization for cell therapeutics must obtain a license to handle human cells, which is separate from the license to manufacture advanced biopharmaceuticals.
The license allows GC Cell to produce cell therapeutics faster than any other contract development and manufacturing organization (CDMO) companies in Korea.
In 2020, the company’s CDMO sales to Artiva Biotherapeutics in the United States and GC LabCell surged 524 percent on year. It plans to expand its CDMO business to boost profits in 2021.