PCT to Manufacture Phase 3 Cell Therapy Product for Kiadis Pharma
PCT Team | June 21, 2016
PCT has expanded its relationship with Kiadis Pharma (Euronext Amsterdam and Brussels: KDS) (“Kiadis”), by entering into an agreement for the manufacturing of cell therapy product for United States and Canada clinical trial sites for a Phase 3 trial of Kiadis’ lead product, ATIR101™, for the treatment of blood cancers.
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, New Jersey 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 in the United States,” said Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis. “The manufacture and supply of study medication for our Phase 3 clinical trial with ATIR101™ in the United States 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 United States.”
“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 A. Preti, PhD, President of PCT. “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.”
PCT TeamOur leaders have worked on some of the major cell therapies of the past 20 years, and have extensive experience in pharmaceutical-grade quality and operations.
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