Company
Business
Stem Cell Therapy
Organoid
CDMO Business
IR Resource Center
Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
Initiation of CMO consignee patient administration
10
2025.03
Clip's BNC, the CMO(contract manufacturer organization) partner of Kangstem Biotech, has initiated Phase 2 clinical trials for its cell therapy and started patient dosing.
Clip's BNC, the CMO(contract manufacturer organization) partner of Kangstem Biotech, has initiated Phase 2 clinical trials for its cell therapy and started patient dosing.
This marks the first case among Kangstem Biotech's CDMO projects where clinical trials and patient dosing have commenced. The GMP center is overseeing the culture process, performing quality assessments on the IP(Investigational Product) and is supplying the drug.
Clip's BNC, is conducting a Phase 2 clinical trial in Korea to treat LSCD(Limbal Stem Cell Deficiency). Clip's BNC explained, “Our candidate treatment for ‘LSCD101’ requires the cultivation and transplantation of autologous limbal-derived epithelial cell sheets, which presents challenges in cell purification and culture. This requires precise techniques. Kangstem Biotech, with its expertise and skilled professionals through in-house stem cell R&D, is responsible for everything from scaffold preparation to the entire culture process and quality management as the CMO partner, enabling the production of high-quality medicinal products and a smooth transition into clinical trials.”
This achievement holds significant meaning as it demonstrates Kangstem Biotech's ability to analyze the unique characteristics of rare and difficult-to-treat diseases, establish manufacturing processes, and prove its production capabilities in the field of cell therapy.
Kangstem Biotech’s advanced quality systems, production technologies, and top-tier GMP facilities allow the company to provide comprehensive CDMO services for various cell and gene therapy products. Moving forward, Gangstem Biotech is committed to contributing to the swift and efficient development of new drugs for its CDMO clients.
Kangstem Biotech’s CDMO business encompasses the entire process, from development and production to the cell banks, storage, distribution, and commercialization. We offers comprehensive, customized services to meet the specific needs of its clients.ongoing projects include limbal stem cell treatments, exosome therapies, neural progenitor cell differentiation treatments, and CGT using mRNA.
Additionally, Kangstem Biotech’s GMP center has been recognized by the Gyeongin Food and Drug Administration as a model case for its systematic management of aseptic manufacturing, cell storage, quality control, and overall facility and manufacturing processes.