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news.Progenitor Cell Therapy (PCT) has completed the construction of the initial phase of its new cell therapy development and manufacturing facility in Allendale, New Jersey, which is being built to accommodate increasing client demand for clean room and support space.
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The company-owned 30,000 square-foot facility is expected to provide clients with access to multiple clean room manufacturing suites, each with independent air-handling and laboratory systems, to support PCT’s existing and future clients with projects ranging from process/product development to Phase I-II-III clinical trial, fill/finish operations and commercial product manufacturing.
The company said that the facility has been designed to be compliant with FDA and European Medicines Agency (EMEA) standards for the processing of human cells for therapeutic use. The facility also provides capacity for the storage of client products in a liquid nitrogen (LN2) freezer farm with monitoring and control capabilities.
The development of the company’s new facility is a multi-phase project. The first phase, now completed, provides for new headquarters for the company’s operations and for the initial install of the freezer farm. Subsequent phases already commenced will bring the company’s processing, manufacturing and development capabilities online during the remainder of the year.
Robert Preti, president of PCT, said: “Progenitor Cell Therapy is proud of the work we have performed for clients over the past 11 years in what was our very first manufacturing facility in Hackensack, New Jersey. We are excited to now be moving operations into and serving our clients from our third location, which will allow us to combine our multiple east coast operations into one facility with increased capacity and significant room for continued expansion.”