[Edaily Reporter KIM SAE-MI ] Amicogen ( Amicogen, Inc.(092040)), a company specializing in biomaterials, components, and equipment, announced on the 29th that Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety, visited the biopharmaceutical culture medium plant in Songdo, Incheon, on the 28th to inspect manufacturing and quality control operations and discuss plans for the commercialization of domestically produced culture medium.
This visit was arranged to assess the feasibility of implementing the “Biopharmaceutical Raw Material Certification System”—which is being introduced based on the Special Act on Support for Contract Development and Manufacturing Organizations (CDMO) for Biopharmaceuticals—in a real-world setting.
Domestic biopharmaceutical companies, including Celltrion(068270), Samsung Bioepis, and GC Biopharma Corp., attended the on-site roundtable discussion. The participating companies discussed quality control standards and measures to ensure supply chain stability necessary for incorporating domestically produced culture media into actual production processes.
In particular, key requirements included the management of approximately 100 types of raw materials comprising the culture medium, as well as trace metals and impurities; advance notification when changing raw material suppliers; consistency in culture performance and yield across production lots; and the protection of the confidentiality of medium formulations specific to each client.
Cell culture media are core raw materials used in the production of biopharmaceuticals. Since changes in the raw materials or composition of the media can affect cell growth and drug production yield, ensuring stable quality and performance is crucial for their application in commercial production processes.
Amicogen, Inc. is currently participating as a consulting firm in the process of establishing guidelines for the Raw Material Certification System, in collaboration with the Ministry of Food and Drug Safety (MFDS) and the Vaccine Safety Technology Support Center. The company plans to enhance the manufacturing and quality management systems at its Songdo plant and integrate its proprietary antibody production medium, “UltiMax,” along with its contract manufacturing system for customer-specific medium formulations, with the certification system.
On the same day, Amicogen, Inc. also introduced its AI-powered medium development technology. The company is enhancing an AI-based optimization platform that analyzes medium components, manufacturing conditions, cell growth, and antibody productivity data to design medium formulations tailored to customers’ cell lines and production processes.
Based at its Songdo plant, Amicogen, Inc. is engaged in the manufacture of powdered and liquid media, the supply of its proprietary media and feed solutions, and the development and contract manufacturing of customized media for clients.
Park Cheol, CEO of Amicogen, Inc., stated, “We expect the Raw Material Certification System to serve as a major turning point in linking the localization of core raw materials and components for biopharmaceuticals—which have long been heavily dependent on overseas sources—to actual production sites.” He added, “We will expand the number of commercial production applications in Korea by focusing on two main pillars: our proprietary media and contract manufacturing of media with customer-specific formulations.”
