Excell Therapeutics announced on February 25 that it has completed the U.S. Food and Drug Administration (FDA) Drug Master File (DMF) registration for CellCor MSC CD AOF, its chemically defined culture medium for mesenchymal stem cell (MSC) cultivation.

The DMF system allows manufacturers to register information on raw material production processes and quality control to ensure the safety and quality of pharmaceutical ingredients.

Released in June 2023, CellCor MSC CD AOF is composed entirely of chemically defined components, containing no animal- or human-derived substances. This feature slows cell aging while reducing immunogenicity and inflammatory gene expression, according to the company.

Excell Therapeutics also highlighted the medium’s broad applicability in culturing MSCs derived from various tissues, including adipose tissue, bone marrow, umbilical cord blood, and Wharton’s jelly. Additionally, it can be used for the production and research of stem cell-derived exosomes.

Lee Eui-Il, CEO of Excell Therapeutics, stated, “Completing the FDA DMF registration marks a critical turning point in strengthening our competitiveness in the global chemically defined media market. With increasing regulatory restrictions on animal- and human-derived materials, chemically defined media are no longer an option but a necessity.”

He further noted, “As the cell and gene therapy (CGT) market advances into large-scale production, quality and risk management standards for raw materials are becoming more stringent. We expect this FDA registration to position Excell Therapeutics' culture medium as a global industry standard.”