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

• 14,000+ cell therapy procedures
• 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 two cell therapy facilities, one in Hackensack, New Jersey and the other 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). The 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.