Kolon Life Science announced on the 13th that its subsidiary Kolon Biotech has obtained five necessary permits for contract development and manufacturing of advanced biopharmaceuticals (CDMO) and contract manufacturing (CMO) at its Chungju Bio 1 Plant. The company plans to expand various customer-tailored cell therapy production services, including the establishment of a cell bank.
The Chungju Bio 1 Plant, which was completed in 2014, has sequentially obtained approvals between July and November of this year for: △ human cell management, △ advanced biopharmaceutical manufacturing, △ compliance with the Good Manufacturing Practice (GMP) standards for the manufacturing and quality control of raw pharmaceutical products at contract manufacturers, △ compliance with GMP standards for finished pharmaceutical products at contract manufacturers, and △ cell processing facility permits.
With this approval, it has become possible to collect, analyze, and process human cells to supply them as raw materials for advanced biopharmaceuticals. It is also now possible to supply the collected, analyzed, and processed human cells to regenerative medical institutions. Kim Sun-jin, CEO of Kolon Biotech, noted, "As a result, the Kolon Biotech Chungju Plant can now provide services throughout the entire life cycle of advanced biopharmaceuticals and is ready to become a leading manufacturer and supplier of advanced biopharmaceuticals."
The 1st Plant provides various scale contract development and manufacturing (CDMO) services from the production of clinical samples domestically and internationally to initial commercial supply. Adjacent to it, the 2nd Plant, which has a facility size of 17,000 square meters at cGMP (Current Good Manufacturing Practice) standards, is equipped with an advanced process system capable of large-scale cell culture and filling more than 10,000 vials per hour. Kolon Biotech has successfully carried out over 100 batches of clinical and commercial production for domestic and international clients, meaning it has successfully conducted the manufacturing process without quality issues over 100 times. In August, a process development contract was signed with Kolon TissueGene and Kolon Life Science to establish a mass production system for the osteoarthritis treatment 'TG-C' (formerly InvoCell) that Kolon TissueGene is researching and developing.