Cellectis 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, North Carolina, 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 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 Dr. André Choulika, Chairman and CEO of 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 currently manufactures its allogeneic UCART clinical trial supply and starting materials through contract manufacturing organizations (CMO). 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.