MINNEAPOLIS, Dec. 20,
2023 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ:
TECH) today announced that it has filed a Drug Master
File (DMF) with the U.S. Food and Drug
Administration (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 (IND) applications
with the FDA.
"Minimizing variability is the keystone to success when
developing stem cell-based therapies. Our ExCellerate iPSC
expansion media offer consistent, scalable performance, enabling
our customers to develop life changing therapies faster," said
Will Geist, President of
Bio-Techne's Protein Sciences Segment. "We are proud to provide our
cell therapy customers with reliable workflow solutions and
analytics tools for consistent and precise cell manufacturing. This
recent DMF submission is yet another example of our commitment to
support our customers with the highest-quality reagents and the
documentation required for regulatory approval of their novel stem
cell-based therapeutics."
About Bio-Techne Corporation (NASDAQ: TECH)
Contact: David Clair, Vice
President, Investor Relations & Corporate Development
david.clair@bio-techne.com
612-656-4416
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SOURCE Bio-Techne Corporation