GC Cell-Cellab Med Sign CDMO Agreement for Solid Tumor CAR-T Cell Therapy

[Asia Economy Reporter Chunhee Lee] GC Cell (GC Cell) announced on the 11th that it has signed a contract for contract development and manufacturing organization (CDMO) to produce clinical trial drugs for solid tumor-targeting chimeric antigen receptor (CAR)-T therapy with Cellab Med.

Through this contract, GC Cell will carry out the production and quality testing of Cellab Med's solid tumor-targeting CAR-T therapy drug ‘YYB-103’ for phase 1 clinical trials.

CAR-T therapies require cell therapy production technology and gene manipulation processes, demanding advanced technical expertise in establishing manufacturing processes and quality control standards. In Korea, only CAR-T therapies targeting hematologic cancers have been approved and clinically authorized, and Cellab Med has received approval for the first domestic phase 1 clinical trial application (IND) targeting solid tumors (brain cancer) patients. Accordingly, there has been no successful case of CDMO for clinical trial drugs targeting solid tumor CAR-T therapies in Korea. To this end, the two companies have conducted over a year of technology transfer and product manufacturing consultations, and will immediately begin production of clinical trial drugs through this main contract.

Lee Yong-seok, Head of Production at Cellab Med, said, “GC Cell is a company possessing both advanced biopharmaceutical manufacturing and CDMO experience, making it the optimal partner for YYB-103 production,” and added, “We expect rapid progress and results in phase 1 clinical trials through this contract.”

GC Cell has accumulated manufacturing achievements in the cell and gene therapy (CGT) field since 2007 and is conducting CDMO not only with Cellab Med but also with various other companies. At the 'Cell Center,' the largest cell therapy production facility in Korea, GC Cell applies manufacturing and quality testing know-how based on its production record to the latest equipment and systems. GC Cell was also the first domestic advanced biopharmaceutical manufacturing company to obtain the ‘Human Cell Management Business License.’ Furthermore, it has acquired licenses for advanced biopharmaceutical manufacturing, advanced biopharmaceutical products, and cell processing facilities, completing all necessary guidelines for CDMO.

Park Jong-won, Head of Production at GC Cell, said, “This contract is significant as it is the first domestic CDMO for clinical trial drugs targeting solid tumor CAR-T therapies,” and added, “We plan to secure a dominant position as a leading company at the starting stage of the domestic CGT contract development and manufacturing industry.”

This content was produced with the assistance of AI translation services.