Development and manufacturing services provider PCT has expanded its relationship with Kiadis Pharma by entering into an agreement for the manufacturing of cell therapy product for U.S. and Canada clinical trial sites for a Phase 3 trial of Kiadis’ lead product, ATIR101, for the treatment of blood cancers.

PCT is a subsidiary of cell therapy company Caldrius Biosciences.

To date, PCT has provided engineering and process development services for Kiadis, which included optimizing its manufacturing process to incorporate functionally closed processing. Work is currently underway at PCT’s Allendale, NJ, facility to expand its clean room capacity by 60% and to develop and implement cell therapy specific pharmaceutical grade quality systems.

“We are pleased to select PCT as our contract manufacturing organization (CMO) in the U.S.,” said Manfred Rüdiger, chief executive officer, Kiadis. “The manufacture and supply of study medication for our Phase 3 clinical trial with ATIR101 in the U.S. and Canada is a critical component to the successful and smooth running of our clinical study and having a partner who is well established and highly experienced, like PCT, is very important. PCT has been an excellent advisor and provider of process development to Kiadis in the past and we look forward to leveraging those efforts as we begin to broaden the activities of Kiadis in the U.S.”

“We are pleased to expand our relationship with Kiadis to help bring new cell therapies to patients in need. Our Kiadis partnership is an excellent example of PCT’s growth strategy in motion—initiation of process and manufacturing development partnerships that subsequently expand to clinical manufacturing projects. Our strategy is for our partnerships to culminate, upon regulatory approval of client products, with commercial-scale manufacturing and advancement towards the cell therapy factory of the future,” said Robert Preti, president, PCT, and senior vice president, manufacturing and technical operations and chief technology officer, Caladrius Biosciences. “A growing number of cell therapy developers are partnering with PCT to take advantage of our quality, scalable, innovative, reliable, and cost-efficient manufacturing platforms and services to advance commercialization of cellular therapies.”