Progenitor Cell Therapy leads the industry in the contract manufacture of cell therapy products

Progenitor Cell Therapy's industry track-record includes experience manufacturing a wide variety of cell, gene, and tissue types. We leverages our multi-product experience to benefit our clients in a way that places paramount importance on protecting the quality and proprietary aspects of each client"s product.

Partnering with Progenitor Cell Therapy to manufacture your cell therapy products ensures maximum cost-effectiveness, regulatory compliance and timeliness-to-market.

Our Manufacturing Experience

• 5,000+ patients have received products manufactured by PCT
• 14,000+ cell therapy procedures performed
• 10,000+ cellular products manufactured
• Participation in more than 50 clinical trials in the US and Europe

Our Solutions
Through our contract manufacturing partnerships, we have assisted our clients in overcoming the following intrinsic cell manufacturing challenges:

• Substantial capital and resource commitments
• Limited unit size
• Short turnaround time between collection and delivery
• Product characterization
• Limitations of manufacturing infrastructure, personnel, and investment capital
• Process scalability
• Increasingly stringent regulatory requirements

Our Quality Systems Approach
We use a Quality Systems Approach that ensures cGMP/cGTP compliance in critical areas including:

• Materials, equipment and facilities controls
• Deviation, Corrective and Preventative Action (CAPA),
• Change and document controls
• Validation
• Auditing (Internal and external)
• Training

Our Facilities
We currently have three cell therapy facilities, one in Hackensack, New Jersey, another in Allendale, NJ and one in Mountain View, California. Our manufacturing facilities are designed to meet the accreditation requirements of the Foundation for the Accreditation of Cellular Therapy (FACT) and to comply with the FDA's cGMPs and cGTPs. The facilities are also in compliance with all other state and federal regulatory and licensing requirements.

The Hackensack manufacturing facility is a 2,500 square foot, state-of-the-art facility located on the campus of Hackensack University Medical Center (HUMC). This is PCT's original facility and is scheduled to be phased out as operational transfers are made to the new facility in Allendale, NJ. The Hackensack facility has 1,150 square feet of clean room space that meets the highest current standards for air quality and flow, as required for the performance of a range of cell therapy and clinical trial activities. The QC laboratory and pre-clinical research and development areas are fully equipped and total approximately 3,300 square feet. Between 1999 and 2005, the Hackensack facility performed over 14,000 cell therapy procedures including over 6,500 umbilical cord blood products. Presently the manufacturing facility continues to process at the rate of over 1,300 products per year.

Our manufacturing facility in Mountain View, California is a fully staffed, fully functioning and licensed cell therapy manufacturing facility of approximately 25,500 square feet of clean rooms, support rooms, offices, and some readily convertible space for additional clean room area that can be built per customer spec. This facility also has multiple process and product development suites equipped with the necesary equipment for all type of development projects related to production, testing, charaterization, scale-up, assay development, etc.

The Allendale facilty is PCT's newest facility. It was acquired to transition PCT's East Coast manufacturing operation from the Hackensack facility as well as to provide ample capacity to expand PCT's growing operation. The company-owned 30,000 square-foot facility will 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 facility has been designed to be compliant with U.S. Food & Drug Administration (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 state-of-art 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.