[Edaily Reporter Kim Seung-kwon] #Excel Therapeutics, a company specializing in chemically defined media for cell and gene therapies (CGT), announced on the 16th that it has officially begun the process of registering a Master File (MF) with the PMDA (Pharmaceuticals and Medical Devices Agency) to enter the Japanese market and apply for commercialization of its therapeutic products.

This MF registration is being pursued for “CellCor™ MSC CD AOF,” a chemically defined medium specifically designed for mesenchymal stem cells, which will be applied to the CARTISTEM® commercialization project in Japan recently announced by #Medipost. The company recently completed the selection of a local Japanese consulting firm and has begun formulating a registration strategy and compiling submission materials.

The PMDA MF is a system for registering information related to manufacturing processes, quality control, and safety of raw materials used in the production of regenerative medical products and pharmaceuticals, and is one of the key regulatory procedures for entering the Japanese market. Once MF registration is complete, client companies will be able to submit relevant documentation and respond to regulatory requirements more efficiently.

Excel Therapeutics previously demonstrated its global regulatory compliance capabilities by becoming the first company in Korea to complete U.S. FDA DMF registration for a chemically defined medium for mesenchymal stem cells last year. Building on the quality management system and regulatory expertise accumulated through this achievement, the company is now pursuing PMDA MF registration in Japan.

The company plans to first complete MF registration for the 500mL bottle product ‘CellCor™ MSC CD AOF’ by early next year, then expand the registration scope to include large-volume bag-type products suitable for commercial production, thereby gradually establishing a supply base for the Japanese market by the end of next year. Through this, the company intends to establish a product supply system capable of flexibly adapting to various production scales and usage environments.

Lee Eui-il, CEO of Excel Therapeutics, stated “This drive for PMDA MF registration is a key procedure to support Medipost’s commercialization project for Cartistem in Japan, and it will serve as an important milestone marking the application of a chemically defined medium developed with our proprietary domestic technology to cell therapies at the global commercialization stage,” he said. “In particular, we expect this to create achievements in localization within the field of core bio-materials, which demands high technical capabilities and quality competitiveness, and to serve as an opportunity to enhance the competitiveness of the domestic bio-materials and components industry.”