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To manufacture clinical batches of Cellectis’ lead engineered T-cell product candidate
January 20, 2016
By: Kristin Brooks
Managing Editor, Contract Pharma
Cellectis has entered into a new agreement with CELLforCURE for the cGMP manufacture of UCART123 clinical batches, Cellectis’ lead engineered T-cell product candidate. This agreement follows the recent successful production of UCART19. CELLforCURE, the largest industrial facility for clinical and commercial production of cell therapies in Europe, will implement cGMP manufacturing processes designed and developed by Cellectis. UCART123 targets CD123, an antigen expressed on the surface of cancer cells in malignancies, such as acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cells neoplasm (BPDCN). UCARTs (Universal Chimeric Antigen Receptor T-cells) are “off-the-shelf” allogeneic product candidates and their production can be industrialized and standardized with consistent pharmaceutical release criteria, over time and from batch to batch. Dr. David J.D. Sourdive, executive vice president Corporate Development, Cellectis, said, “The manufacturing campaign for UCART123 consolidates Cellectis’ GMP processes and our expertise in its industrialization while allowing Cellectis to further enhance and improve the manufacturing of its UCART product candidates.” Pierre-Noël Lirsac, chief executive officer of CELLforCURE said, “The technical and pharmaceutical experience of the CELLforCURE team is a real asset, bringing its expertise to manufacture Cellectis’ cost-effectively CAR T-cell products, thus helping to make them broadly and immediately available to patients.”
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