Cellectis will build a clinical and commercial production plant in Raleigh at a reported cost of $68 million and a raw material facility in France to support its allogeneic CAR-T pipeline.
France-headquartered Cellectis is looking to develop off-the-shelf chimeric antigen receptor (CAR) T-cell therapies using its TALEN gene-editing technology.
Cellectis manufactures its allogeneic UCART clinical trial supply and starting materials through contract manufacturing organizations (CMOs) but is now looking to securing inhouse supply through investments in Raleigh, North Carolina, and France.
A spokesperson from the firm told this publication that the Raleigh facility, known as the IMPACT plant â€“ Innovative Manufacturing Plant for Allogeneic Cellular Therapies â€“ will be used for clinical and commercial production of Cellectisâ€™ allogeneic UCART products when operational, expected by 2021.
The site will create up to 200 jobs, the spokesperson said, and while the level of the investment has not been disclosed Research Park Triangle publication WRAL TechWire puts the figure at $68 million (â‚¬60 million).
Meanwhile, the firm is building a plant in Paris, known as the SMART â€“ Starting Material Realization for CAR-T products â€“ facility, set to produce critical starting material supply for UCART clinical studies and commercial products.
â€śWe are entering an exciting phase for Cellectis, internalizing manufacturing capabilities and capacity,â€ť AndrĂ© Choulika, CEO of Cellectis, said in statement.
â€śNow 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.â€ť
The firm will continue to use CMOs in unison with its own capabilities, we were told.
â€śThese CMOs will continue to be strategic business partners, complementing IMPACT and SMART plants in assuring a robust supply chain for the manufacture of Cellectisâ€™ allogeneic UCART therapies.â€ť