Cellectis, a biopharma company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), has entered into a lease agreement to build an 82,000 square foot commercial-scale manufacturing facility named IMPACT (Innovative Manufacturing Plant for Allogeneic Cellular Therapies) in Raleigh, NC, for clinical and commercial production of Cellectis’ leading allogeneic UCART products. In addition, Cellectis started building a 14,000 square foot manufacturing facility in Paris, France named SMART (Starting Material Realization for CAR-T products) to produce Cellectis’ critical starting material supply for UCART clinical studies and commercial products.
 
These new manufacturing plants will allow GMP manufacturing for both clinical supplies and commercial products according to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines, and will be fully equipped to support a potential regulatory approval.
 
“As announced in 2018, we are entering an exciting phase for Cellectis, internalizing manufacturing capabilities and capacity. We have perfected our manufacturing process throughout the past years and successfully produced several GMP campaigns at our CMOs, which have been and will remain key partners,” said André Choulika, chief executive officer, Cellectis. “Now is the right time to create our own supply competencies. By combining the state-of-the-art capabilities that IMPACT and SMART plants will provide, Cellectis will gain autonomy, control and expertise in manufacturing operations, allowing us to continue to build competitive advantage and remain the leader in our field.”
 
Cellectis’ leading allogeneic approach begins with harvesting T-cells from healthy donors. These T-cells are then edited using the company’s proprietary gene-editing technology, TALEN, to develop engineered T-cells that express a Chimeric Antigen Receptor (CAR). The engineered T-cells can recognize specific proteins or antigens that are present on the surface of target cancer cells and eliminate them, without being rejected by the body. Once engineered, the UCART products are cryopreserved and ready to be shipped to hospitals across the world.
 
Cellectis currently manufactures its allogeneic UCART clinical trial supply and starting materials through contract manufacturing organizations (CMOs). The company says these CMOs will continue to be strategic business partners, complementing IMPACT and SMART plants in assuring a robust supply chain for the manufacture of Cellectis’ allogeneic UCART therapies.
 
The SMART facility is co-located with the Cellectis headquarters in Paris, France. The engineering team of Laporte Euro is assisting for the design and construction.
 
The IMPACT facility is part of the Sumner Business Park located at 2500 Sumner Boulevard in Raleigh, NC.