Bio-Techne announced a commitment to invest between $40 million and $50 million to expand its GMP-grade protein production capacity. This investment will fund a new facility that is specifically dedicated to supporting the large-scale production of GMP-grade materials, including E. coli-derived recombinant proteins, which are an essential component for many bioprocessing and cell therapy manufacturing workflows.
Cell and gene therapies show great promise for the future of disease treatment. The escalating number of clinical trials utilizing CAR-T cell-, hematopoietic stem cell-, mesenchymal stem cell- or pluripotent stem cell-based products emphasizes the need for the rapid global expansion of protein manufacturing. The current global GMP-grade raw material supply for cell therapy production and industrial large molecule manufacturing is not sufficient to meet future demands. By investing in a new state-of-the-art GMP manufacturing facility, Bio-Techne is anticipating and preparing for the growing demand of such raw material to support the recent and forecasted surge in Investigational New Drug (IND) filings for autologous and allogeneic cell therapies. This corporate infrastructure investment complements the 30-year history of Bio-Techne's R&D Systems™ brand as the industry leader in recombinant protein manufacturing.
"As the promising science behind emerging cell and gene therapy applications continues to demonstrate therapeutic effectiveness, the focus must now be on supply and scale. By investing in a new GMP facility, therapeutic manufacturers can be assured that the highly pure, bioactive R&D Systems GMP-grade proteins they rely on for their manufacturing process will continue to be available as their raw material demands increase through clinical trial, approval, and therapeutic commercialization," Dave Eansor, President of Bio-Techne's Protein Sciences Segment, said.
"The recent success of cell and gene therapies is very exciting,” Chuck Kummeth, President and CEO of Bio-Techne, said. “This investment solidifies our commitment to supporting the future of these new modalities by finding innovative and reliable ways to help companies gain access to scalable quantities and a reliable supply of high-quality, GMP-grade growth factors and cytokines for their manufacturing processes."