Bio-Techne submits Drug Master File with FDA for CCM0036-GMP

Bio-Techne announced that it has filed a Drug Master File with the U.S. FDA for its ExCellerate GMP iPSC Expansion Medium, Animal Free (CCM0036-GMP), supporting the development and manufacture of regenerative medicine and stem cell therapies. ExCellerate GMP iPSC Expansion Medium is optimized to support robust expansion and maintenance of stem cell culture for enhanced consistency and reproducibility throughout the stem cell manufacturing process. The recently released GMP medium complements Bio-Techne’s industry leading regenerative medicine therapy workflow solutions, which includes the widest range of GMP cytokines and growth factors available on the market. The ready-to-use media is manufactured without the use of animal components and is available in preclinical and GMP grades to simplify transition from research to clinic. The DMF submission provides the FDA with detailed information about the facilities and processes used in the manufacturing, processing, packaging, and storing of ExCellerate GMP iPSC Expansion Medium. Regenerative medicine and stem cell therapy developers who integrate the medium into their GMP cell manufacturing workflows can easily reference these important details when filing Investigational New Drug applications with the FDA.