KangStem Biotech said that it has signed a contract development and manufacturing organization (CDMO) contract with YJ Cerapeutics to treat cross-differentiated neural progenitor cells.

Under the accord, KangStem will develop and produce YJ Cerapeutics' cross-differentiated neural progenitor cell therapeutics and provide customized manufacturing process development solutions.

Notably, KangStem plans to provide a comprehensive service from the company's stem cells and media to producing high-quality non-clinical and clinical samples based on stem cell treatment R&D and good manufacturing practice (GMP) operating know-how so that YJ Cerapeutics can successfully conduct clinical trials.

"Through various clinical trials, including the global-level stem cell GMP center and phase 3 clinical trials, the company has acquired the ability to participate in the entire process, including cell production, drug production planning, development, and commercialization," said Kim Won-kyun, head of KangStem Biotech GMP Center.

Through the CDMO business, Kim added that the company is recently emerging as a differentiated GMP facility by improving the safety of production of cell therapy products, management of production facilities, and technological proficiency.

KangStem Biotech started its CDMO business based on cell therapy with the approval of manufacturing advanced biopharmaceuticals in Dec. 2020.

Last year, the company landed three projects and conducted quality tests, including limb stem cell production and test method validation and quality tests related to exosome production.

In addition, the company's facility provides umbilical cord blood stem cells as a starting material for cell gene materials and manufactures and supplies cell gene therapy products for non-clinical and clinical trials of cell therapy products, the official added.