Bio-Techne Corporation (NASDAQ: TECH) has recently submitted a Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for its ExCellerate™ GMP iPSC Expansion Medium, Animal Free (CCM0036-GMP), marking a significant step in advancing regenerative medicine and stem cell therapies.

The ExCellerate GMP iPSC Expansion Medium is specifically designed to facilitate robust expansion and maintenance of stem cell cultures, ensuring enhanced consistency and reproducibility throughout the stem cell manufacturing process. It complements Bio-Techne's comprehensive regenerative medicine therapy workflow solutions, which include a leading range of GMP cytokines and growth factors. Notably, it is manufactured without the use of animal components and is available in preclinical and GMP grades, streamlining the transition from research to clinical applications.

The DMF submission provides the FDA with detailed information regarding the facilities and processes involved in the manufacturing, processing, packaging, and storage of ExCellerate GMP iPSC Expansion Medium. This information is particularly beneficial for developers in the regenerative medicine and stem cell therapy field, allowing them to reference crucial details when preparing Investigational New Drug (IND) applications with the FDA.

Will Geist, President of Bio-Techne's Protein Sciences Segment, emphasized the significance of minimizing variability in the development of stem cell-based therapies. Geist highlighted that the ExCellerate iPSC expansion media contribute to consistent and scalable performance, enabling customers to accelerate the development of life-changing therapies. He expressed pride in providing cell therapy customers with reliable workflow solutions and analytics tools, emphasizing the commitment to delivering high-quality reagents and necessary documentation for the regulatory approval of novel stem cell-based therapeutics. The recent DMF submission underscores Bio-Techne's dedication to supporting its customers in this critical aspect of therapeutic development.

 

Source: prnewswire.com

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