Located at 2500 – 2540 Sumner Boulevard in Raleigh, NC, the new USA facility is owned by Equus Capital Partners and will be used for clinical and commercial production of Cellectis’ leading allogeneic UCART products.
Importantly, the decision will combine the capabilities of Cellectis’ two facilities to advance its manufacturing processes and prepare for potential commercialization of its UCART products in the future.
Cellectis’ CAR-T Cell Therapy: UCART
Founded in 1999, Cellectis is a clinical-stage company focused on developing allogeneic cancer immunotherapies based on gene-edited T-cells (UCART). With 20 years of expertise in the field of gene-editing, the company has developed a proprietary gene-editing (TALEN®) technology, as well as an cutting-edge electroporation system (PulseAgile).
The company’s UCART product is created by using its TALEN® technology to develop engineered T-cells that express a chimeric antigen receptor (CAR). The resulting T-cells can identify unique antigens on the surface of cancer cells and destroy these cells without being rejected by the patient.
Once manufactured, its UCART products can be cryopreserved and shipped to hospitals worldwide.
Cellectis’ UCART Manufacturing Plants
The company’s Raleigh, NC, facility is named IMPACT, an acryonym which stands for “Innovative Manufacturing Plant for Allogeneic Cellular Therapies.” The company’s Paris, France, facility is called SMART, an acryomn which refers to “Starting Material Realization for CAR-T products.”
According to Cellectis, its 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.”
Providing further details, Dr. André Choulika, Chairman and CEO of Cellectis, states: “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. 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.”
Cell Therapy Manufacturing
Interested to learn more about cell therapy manufacturing? View BioInformant’s “Database of Cell and Gene Therapy CMOs / CDMOs.”
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