MINNEAPOLIS, Sept. 30, 2020 /PRNewswire/ — Bio-Techne Corporation (NASDAQ: TECH) today announced the grand opening of its approximately 61,000 square foot state-of-the-art GMP (Good Manufacturing Practices) manufacturing facility. Located in St. Paul, MN, the new facility is dedicated to supporting large-scale production of GMP-grade materials, including E. coli-derived recombinant proteins, which are an essential component for many immuno-oncology and regenerative medicine cell and gene-modified therapy workflows. The advent of both chimeric antigen receptor T cell therapies (CAR T) and stem cell therapies has significantly increased the demand for GMP grade recombinant proteins. The opening of this facility positions Bio-Techne to meet current and future demand for the GMP-grade reagents necessary to support the rapidly growing cell therapy market.
Bio-Techne invested approximately $50 million to build the new facility and equip it with the advanced manufacturing and quality control technologies needed to produce products for cell and gene therapies. The process of culturing cells for therapeutic use requires precise amounts of specific biological proteins to support cell growth and development. Bio-Techne has decades of experience in manufacturing these proteins. With multiple fermenters and purification suites, this new facility will now allow Bio-Techne to manufacture the large quantities of proteins under the GMP quality conditions required for use in the manufacturing of cells for therapeutic applications. Following extensive quality validation procedures, the facility is expected to begin production in early 2021.
Cell and gene therapies are rapidly growing fields of medicine that introduce natural or genetically modified cells into patients’ bodies to treat disease or repair damaged tissues, representing the next paradigm in treating difficult clinical indications. Initial successes in immuno-oncology have propelled the market forward, enabling many commercial and research institutions to develop novel cell therapeutic modalities, creating a rich pipeline of potential therapies. These cell and gene therapies provide new hope to patients where traditional therapies were previously unavailable or failed over time.
“Bio-Techne is the global leader in manufacturing research-grade proteins, with our R&D Systems brand widely recognized for the highest level of purity, bioreactivity and lot-to-lot consistency,” commented Chuck Kummeth, Bio-Techne’s President and Chief Executive Officer. “GMP proteins are an essential ingredient for the production of cell and gene therapies. With over 1,000 cell and gene therapies in various phases of clinical trials globally, we anticipate demand for GMP-grade proteins to dramatically increase going forward, representing a potential bottleneck in the cell and gene therapy workflow. Bio-Techne’s global recognition combined with our state of the art GMP manufacturing facility positions us to meet global demand and further solidify our protein leadership position.”
More information on Bio-Techne’s portfolio of products for Cell & Gene Therapy workflow can be found at www.bio-techne.com/research-areas/cell-and-gene-therapy.