Bio-Techne announces commercial availability of GMP-grade proteins from dedicated GMP facility

Bio-Techne Corporation has announced the commercial availability of GMP-grade materials manufactured at its St. Paul, MN GMP (Good Manufacturing Practices) manufacturing facility. The facility is dedicated to supporting the large-scale production of GMP-grade proteins, including animal-free cytokines and growth factors, that are essential components of cell culture media for immuno-oncology, regenerative medicine, and gene-modified cell therapy workflows. Cell therapies are rapidly growing fields of medicine that introduce living cells into patients to treat disease or repair damaged tissue functions. These next-generation treatments show remarkable promise and represent new hope where traditional therapies may have failed.

As described in a recent article in Nature, in 2021 there were more than 1300 ongoing cell therapy clinical trials worldwide, an increase of 43% over the previous year. The rapidly growing number of trials and ultimate push toward commercialization has resulted in an increasing need for larger quantities of GMP-grade animal-free proteins used in clinical manufacturing. For Bio-Techne and its new facility, this means large-scale production of proteins with lot-to-lot consistency, GMP process capabilities for patient safety, and the scalability necessary to support large clinical trials and future successful therapeutics. Bio-Techne invested approximately $50 million to build the new facility and has equipped it with state-of-the-art manufacturing and quality control technologies. With multiple fermenters, purification suites, and room for future expansion, the new facility places Bio-Techne in an excellent position to meet anticipated future demand.

“Bio-Techne is the global leader in research-grade proteins and has experienced rapid recent growth in GMP-grade proteins,” commented Chuck Kummeth, Bio-Techne's President and Chief Executive Officer. “Our new facility gives us the scalability and capacity to bring our GMP-grade protein business to the next level, providing a reliable source of the highest quality proteins to support the rapidly growing cell and gene therapy market. It’s been exciting to watch our site in St. Paul, MN successfully complete the qualification process and we look forward to playing our part in the world’s most innovative science and medicine.”

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