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TxCell Selects PCT as U.S. Mfg. Partner

March 16, 2016

To provide future manufacturing of TxCell’s clinical supply in the U.S.

TxCell SA, a biopharma company developing personalized cellular immunotherapies using regulatory T-cells to treat inflammatory and autoimmune diseases, has selected PCT as its contract manufacturing organization in the U.S. The relationship may transition to a technology transfer, with PCT having responsibility for the future manufacturing of TxCell’s clinical supply in the U.S.
PCT, a subsidiary of Caladrius Biosciences, is a development and manufacturing partner for cell therapies. PCT helps clients overcome fundamental challenges of cell therapy manufacturing with a range of services, from process development to GMP manufacturing and logistics.
“Entering into a strategic relationship with PCT for the future manufacturing of TxCell’s products in the U.S. is yet another step in the advancement of the clinical development of TxCell’s product portfolio,” said Dr. Miguel Forte, senior vice president, chief operating officer of TxCell. “Ovasave, TxCell’s lead product developed in refractory Crohn disease, now has both an open IND as well as a Fast Track Designation in the US. In addition, Col-Treg has recently obtained Orphan Drug Designation in non-infectious uveitis in the U.S. TxCell will conduct a first clinical trial with our products in the U.S. with materials manufactured by PCT. TxCell also will plan to examine options for manufacturing in Asia, and specifically Japan.”
“PCT is proud that such an innovative cell therapy developer as TxCell has chosen PCT as its U.S. external development and manufacturing partner. Their decision adds further credence to PCT’s international reputation as the partner of choice for cell-based therapy companies,” said Robert A. Preti, Ph.D., president of PCT and senior vice president, Manufacturing and Technical Operations and chief technology officer, Caladrius Biosciences, Inc.