Manufacturing

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.

We currently have two cell therapy facilities, one in Hackensack, New Jersey and the other in Mountain View, California.

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 13,500 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. 

PCT’s manufacturing facility in Mountain View, California is a fully staffed, fully functioning and licensed cell therapy manufacturing facility of approximately 7,800 square feet. Approximately 5,900 square feet of space is dedicated for PCT’s exclusive use, and approximately 1,800 square feet is shared common space. Of the exclusive space, approximately 1,500 square feet is either clean room space, or is readily convertible into an additional clean room area.