Medipost CARTISTEM Enhances Safety, Reduces Production Costs, and Improves Yield with Transition to Domestically Produced Culture Media

Linked to National Project for Outstanding Materials, Parts, and Equipment Companies by the Ministry of Trade, Industry and Energy
A Leading Success Story in Localization of Bio Materials, Parts, and Equipment

On June 10, Medipost announced that it will initiate the application of domestically produced culture media for its Japanese commercialization project of 'CARTISTEM®', an allogeneic umbilical cord blood-derived mesenchymal stem cell therapy.

Culture media are nutrients essential for cell growth and are a core material that determines the proliferation and characteristics of cells. Currently, Korea depends almost entirely on imports for culture media, and the need for localization has been continuously raised in terms of supply chain stability and industrial competitiveness.

This key localization project will apply 'CellCor™ MSC CD AOF', a chemically defined medium exclusively for mesenchymal stem cells, developed and produced with proprietary technology by Excel Therapeutics, a company specializing in cell and gene therapy (CGT) media. Excel Therapeutics' chemically defined media are free from animal- and human-derived substances, overcoming the limitations of existing media and ensuring safety, uniformity, and stable supply. Globally, there are reportedly very few companies with the technology to develop CGT-specific chemically defined media.

The two companies have built a partnership since 2020 and have been conducting tests to apply the chemically defined medium. In particular, in 2023, Medipost was selected as the first biopharmaceutical company to become an “Outstanding Materials, Parts, and Equipment Company” by the Ministry of Trade, Industry and Energy (with a total project budget of 13 billion won), further accelerating the push for domestically produced media. The national project aims to develop “advanced clinical sample manufacturing technology for stem cell therapies based on culture media substituting animal-derived ingredients, enabling global competitiveness.” Medipost is responsible for overall management and leading subproject 1, while Excel Therapeutics is participating in subproject 2. The project period runs from September 2023 to December 2026.

Lee Seungjin, head of Medipost's Global Business Division, co-CEO of its U.S. subsidiary, and CEO of its Japanese subsidiary, who serves as the general manager of the national project, stated, “To proactively respond to the tightening of global regulations, we have expanded collaboration with Excel Therapeutics. By demonstrating equivalence through the media change during the Japanese product approval process and ultimately applying it after market launch, we aim to achieve both production cost reduction and stable supply chain for key materials.”

Excel Therapeutics CEO Lee Euijil said, “We plan to complete the registration of the Drug Master File (DMF) for raw materials with Japan’s PMDA and demonstrate equivalence by early next year, thereby proving the excellence of domestic media. As this is a key material accounting for 10–15% of the cost of therapy manufacturing, if the commercialization of CARTISTEM in Japan is fully launched, it will enable long-term and stable revenue generation.”

Meanwhile, Medipost’s CARTISTEM is a treatment option for severe knee osteoarthritis, and since its approval in Korea in 2012, over 36,000 procedures have been performed, making it a leading therapy. Recently, following the demonstration of excellent efficacy and safety in phase 3 clinical trials in Japan, the company is set to begin the biologics license application (BLA) process. Previously, Medipost secured exclusivity for Japanese distribution by entering into an exclusive sales agreement with Teikoku Pharma, including 26.4 billion won in upfront and short-term regulatory milestone payments, further enhancing the commercialization outlook.

This content was produced with the assistance of AI translation services.