Caladrius, PCT and TrakCel to Drive Cell Therapy Manufacturing Excellence
Companies will Collaborate on Cell Therapy Management Technology Implementation
TrakCel Ltd. today announced a collaboration agreement with Caladrius Biosciences, Inc. (Nasdaq:CLBS) and its subsidiary PCT, a Caladrius Company (PCT) to implement its cell therapy process management and supply chain integration technology.
TrakCel’s technology integrates and automates the entire cell therapy process end-to-end while providing real-time audit logs and chain-of-custody records to stakeholders. It further reduces the implementation risks associated with disparate, paper-based systems as TrakCel technology accelerates scale up and scale out of cell therapy processes through immediate access to data for validation and regulatory audits.
Dr. Robert A. Preti, President of PCT and Senior Vice President, Development and Technical Operations and Chief Technology Officer of Caladrius Biosciences said: “We’re committed to providing our clients with industry-leading cell therapy manufacturing founded on exceptional facilities, processes and people. TrakCel’s innovative technology holds significant potential and we are looking forward to realizing its benefits in the near future.”
PCT and TrakCel will undertake in Q4 2015 a design specification stage prior to implementing a customized cell therapy process management solution based on TrakCel’s technology.
“PCT has an unparalleled pedigree in contract manufacturing with over 16 years’ industry experience and over 30,000 products created,” said Kevin Smith, Director, TrakCel. “We’re looking forward to collaborating with PCT as it strives to provide innovative solutions to its clients.”
PCT has full-scale cGMP/GLP operations in New Jersey and California, thousands of square feet of Class 10,000 clean rooms, and full QA/QC support. The company has had over 100 clients whose products have treated over 6,000 patients.
The collaboration agreement supports UK-based TrakCel’s strategy to expand into the US market, and comes ahead of the company’s plan to establish US offices in 2015.