Cellectis builds GMP manufacturing facilities in France and the US

Investments are aligned with the company's decision to take manufacturing in-house

Photo as seen on Cellectis LinkedIn page

Cellectis, the French biopharma company with operations in the US, has decided to bring manufacturing in-house. Cellectis prepares to build an 82,000 square foot commercial-scale manufacturing facility in Raleigh, North Carolina (US) and a 14,000 square foot manufacturing facility in Paris, France.

Headquartered in Paris, Cellectis is a biopharma company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART).The company has relied on contract manufacturers (CMOs) to produce clinical trial supply and starting materials for its flagship UCART products.

The project in Raleigh is known as IMPACT; short for Innovative Manufacturing Plant for Allogeneic Cellular Therapies. The new facility will serve clinical and commercial production of Cellectis’ allogeneic UCART products.

Cellectis said it has also started building a 14,000 square foot manufacturing facility in Paris, France. Dubbed SMART —short for Starting Material Realization for CAR-T products— the site will produce Cellectis’ critical starting material supply for UCART clinical studies and commercial products.

In-house GMP manufacturing

Cellectis said these new manufacturing plants will be designed to allow GMP manufacturing for both clinical supplies and commercial products according to the Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. Both will be fully equipped to support potential regulatory approval, the company said.

“As announced in 2018, we are entering an exciting phase for Cellectis, internalising 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," he added.

Allogeneic approach

Cellectis’ allogeneic approach begins with harvesting T-cells from healthy donors. These T-cells are then edited using the company’s proprietary cutting-edge, gene-editing technology, TALEN, to develop engineered T-cells that express a Chimeric Antigen Receptor (CAR).

The engineered T-cells can recognise 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, our UCART products are cryopreserved and ready to be shipped to hospitals across all geographies.

Cellectis currently manufactures its allogeneic UCART clinical trial supply and starting materials through contract manufacturing organisations. This CMOs, Cellectis said, 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. The engineering team of Laporte Euro is assisting for the design and construction.

The IMPACT facility is part of the Sumner Business Park in Raleigh, North Carolina. Colliers International assisted in the real estate transaction.

Companies